MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F SL 65CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, when performing a catheter insertion procedure, the team showed that it was broken, which made it impossible to perform the catheter implant.It was stated the procedure postponed until new item arrives.It was reported this occurred with two devices.This report addresses the second device.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx2410 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redx2410) have been reported from the same facility.
Additional 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 lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged component is confirmed; however, the exact cause is unknown.One 5 fr per-q-cath catheter with stiffening stylet and t-lock inserted and one excalibur introducer were returned for evaluation.An initial visual observation showed use residue on the returned samples.The catheter was returned in two pieces with a break in the catheter tubing just distal to the 37 cm depth marker.Damage was observed on the distal tip and the shaft of the sheath of the excalibur introducer device.The returned catheter pieces were flushed and pressurized with a 12 ml syringe of water and no leaks were found.Both catheter segments were found to be patent to infusion and aspiration.A microscopic observation revealed splitting within the sheath of the excalibur introducer and plastic deformation of the material at the locations of the damage on the sheath.Striations were observed on the break sites of the catheter tubing indicating the catheter was cut with a sharp instrument such as a scalpel or scissors.Striations were also observed on the most distal end of the catheter.While the break in the returned catheter was most likely caused by a sharp instrument, the exact cause of the damage observed in the introducer sheath is unknown.Possible contributing factors include excessive force during insertion, insertion technique, and sharp instrument damage.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that on (b)(6) 2022, when performing a catheter insertion procedure, the team showed that it was broken, which made it impossible to perform the catheter implant.It was stated the procedure postponed until new item arrives.On 06/29/2022: add info received: was the product ever used on the patient? the product was checked immediately before use on the patient.Was there any harm to the patient/health worker? (details) there was no damage as a problem was evidenced prior to the passage of the catheter.Was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail) it was necessary to request a new catheter to be used in the patient, no other procedure was performed.
Additional 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.
Event or Problem Description
It was reported that on 04/12/2022, when performing a catheter insertion procedure, the team showed that it was broken, which made it impossible to perform the catheter implant.It was stated the procedure postponed until new item arrives.06/29/2022: add info received: was the product ever used on the patient? the product was checked immediately before use on the patient.Was there any harm to the patient/health worker? (details) there was no damage as a problem was evidenced prior to the passage of the catheter.Was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? (detail) it was necessary to request a new catheter to be used in the patient, no other procedure was performed.

• Brand Name: PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F SL 65CM
• Common Device Name: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14706473
• Report Number: 3006260740-2022-02267
• Device Sequence Number: 2201950
• Product Code: LJS
• UDI-Device Identifier: 00801741074905
• UDI-Public: (01)00801741074905
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 4135105
• Device Lot Number: REDX2410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 09/14/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/25/2022; 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female