MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET BASIC TRAY (30 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Bruise/Contusion (1754)

Event Date 08/22/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of rect0098 showed thirteen other similar product complaint(s) from this lot number.

Event Description

It was reported that while introducing the device into patient's right upper limb basilic vein, over the 20 cm deep, there was resistance with leakage (fluid leak due to a perforation in the catheter) in the beginning of the picc, near to the lumen connector (evidenced by flush with saline solution 0.9%).It was required to remove the device and interrupt the procedure.Additional information received, and updated on 31.Aug.2020: the patient presented a bruise due to the puncture, treated with bandages and reparil (edema relief gel); the procedure was not completed.It was decided to perform the maintenance of the central venous catheter through right femoral vein; patient identifiers are: female gender, 16 days old, (b)(6) weight.

Event Description

It was reported that while introducing the device into patient's right upper limb basilic vein, over the 20 cm deep, there was resistance with leakage (fluid leak due to a perforation in the catheter) in the begining of the picc, near to the lumen connector (evidenced by flush with saline solution 0.9%).It was required to remove the device and interrupt the procedure.Additional information received, and updated on 31.Aug.2020: - the patient presented a bruise due to the puncture, treated with bandages and reparil (edema relief gel); - the procedure was not completed.It was decided to perform the maintenance of the central venous catheter through right femoral vein; - patient identifiers are: female gender, 16 days old, 3115 g weight;.

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), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of catheter leak is inconclusive due to poor sample condition.Two photo samples of a per-q-cath catheter were provided for evaluation.The first photo provided showed a product label of a bard per-q-cath plus catheter kit.The product information showed lot: rect0098.The second photo shows a 2 fr perqcath catheter on the kit tray without additional accessory components.The stylet t-lock assembly is present within the catheter.The catheter is also shown fully advanced through the microintroducer sheath.The catheter could not be clearly inspected for the presence of a split or damage.Possible contributing factors include sharp instrument, stylet, or tensile damage.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Since the complaint could not be confirmed from the photo samples provided, the complaint remains inconclusive at this time.A lot history review (lhr) of rect0098 showed thirteen other similar product complaint(s) from this lot number.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET BASIC TRAY (30 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10544533
• MDR Text Key: 207543009
• Report Number: 3006260740-2020-03264
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074837
• UDI-Public: (01)00801741074837
• Combination Product (y/n): N
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 4132105
• Device Lot Number: RECT0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Event Location: Hospital
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 DA
• Patient Weight: 3