MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2022

Event Type  malfunction  

Event Description

It was reported by healthcare professional "requested a picc placement in pediatric icu patient.However, when passing the picc and removing the guidewire, it did not come out.3 more puncture attempts were tried, again, and the issue happened again.A new catheter was used." 11/23/2022 additional information: it was reported, there was an exposure in a procedure that was not successful due to the material used.Dissatisfaction of the doctor and family members and frustration for the procedure did not work.11/28/2022 additional information: it was reported, the patient¿s hospital stay was not prolonged due to the unsuccessful picc placement, but it could have optimized the time if the first pass was successful.1/6/2023 - found during evaluation, the returned stylet exhibited multiple kinks and bends.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the stylet was difficult to remove from the catheter was confirmed but the cause is unknown.A series of a dozen photographs were returned for evaluation of this complaint.Two of the photographs were of the device packaging; the printed part number and batch number aligned with the information recorded in the complaint file.The remaining ten photographs were of the implicated 3fr s/l per-q-cath catheter and the coiled hydrophilic stylet.The stylet had been completely removed from the catheter prior to the photographs being taken.The t-lock assembly was not attached to the stylet which may indicate that the stylet was removed through the septum of the t-lock assembly instead of removing the t-lock assembly and stylet as a unit.The stylet contained multiple bends and kinks which may be indicative or a difficult catheter placement or difficulty stylet removal.No breaks were seen in either the coil or core wire of the stylet.The observable features on the submitted photographs suggested difficulty during the catheter placement.However, the photographs did not contain enough information to identify a specific root cause of the reported problem.Possible contributing factors could include placement of the catheter through a tortuous path, a venospasm restricting the stylet in the catheter, damage to the hydrophilic coating, improper hydration of the hydrophilic coating on the stylet, dimensional incompatibility between components, or removing the stylet through the septum of the t-lock assembly causing additional friction.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.The ifu contains detailed instructions on hydrating the stylet and removing the t-lock assembly and stylet as a unit.The ifu cautions, ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.Once the stylet is out, advance the catheter into the desired position.¿ a lot history review (lhr) of refw2433 showed two other similar product complaint(s) from this lot number.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a difficult stylet removal is confirmed but the exact cause remains unknown.One 3 fr perqcath catheter was returned for evaluation.A product packaging label indicating lot: refw2433 was also returned.Twelve additional photo samples were also provided.The photos depicted the product packaging, stylet, and catheter.The items shown in the photos corresponded with the returned physical sample.The stylet was returned outside of the catheter.The distal end of the stylet contained multiple wavy bends one of the bends created a partial loop with itself.Microscopic inspection of the stylet did not reveal any fraying of the stylet wire.The catheter was flushed with water and no leaks were observed.The stylet was able to be re-inserted through the catheter: however, difficulty was experienced due to the deformation present.Based on the description of the reported event and condition of the returned sample, possible contributing factors include resistance caused by bending of the stylet, advancement or retraction against resistance, and lack of hydrating the stylet prior to use.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.The ifu contains detailed instructions on hydrating the stylet and removing the t-lock assembly and stylet as a unit.The ifu cautions, ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.Once the stylet is out, advance the catheter into the desired position.¿ since the bends present in the stylet are likely contributing factors to the difficult removal, the complaint is confirmed; however, the exact contributing factors remain unknown.

Event Description

It was reported by healthcare professional "requested a picc placement in pediatric icu patient.However, when passing the picc and removing the guidewire, it didn't come out.3 more puncture attempts were tried again, and the issue happened again.A new catheter was used." on 11/23/2022: additional information: it was reported, there was an exposure in a procedure that was not successful due to the material used.Dissatisfaction of the doctor and family members and frustration for the procedure did not work.On 11/28/2022: additional information: it was reported, the patient¿s hospital stay was not prolonged due to the unsuccessful picc placement, but it could have optimized the time if the first pass was successful.On 1/6/2023 : found during evaluation, the returned stylet exhibited multiple kinks and bends.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16237482
• MDR Text Key: 308669662
• Report Number: 3006260740-2023-00109
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REFW2433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 YR
• Patient Sex: Male
• Patient Weight: 15 KG