MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH 4F DUAL-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WITH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebw0616 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when opening the product to use it in procedure, it was verified that it was perforated.Device was not used on the patient.
Event or Problem Description
It was reported that when opening the product to use it in procedure, it was verified that it was perforated.Device was not used on the patient.
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, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a punctured catheter was inconclusive due to poor sample condition.Two photo samples and one video sample of a dl perqcath catheter were provided for evaluation.The first photo sample appears to show the perqcath and stylet within a plastic bag.A sticker label containing patient information is shown.The second photo shows a 4 fr dl perqcath catheter kit label with lot: rebw0616.The video sample shows the perqcath catheter outside of patient use.The green colored lumen is being flushed with a 10 ml slip fit stylet syringe.Water is observed to flow out of the distal end.The use is using a pulse motion during infusion.The syringe is then attached to the second infusion hub and infused.Water is observed to flow out of the distal end.No apparent leaks or catheter damage can be clearly seen through the video provided.Since evidence of the reported issue could not be clearly seen, the complaint remains inconclusive at this time.Based on the description of the reported event, possible contributing factors include stylet damage, sharp instrument damage, and damage during handling.A lot history review (lhr) of rebw0616 showed no other similar product complaint(s) from this lot number.

• Brand Name: PER-Q-CATH 4F DUAL-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WITH
• Common Device Name: 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: 10032155
• Report Number: 3006260740-2020-01687
• Device Sequence Number: 2986778
• Product Code: LJS
• UDI-Device Identifier: 00801741074967
• UDI-Public: (01)00801741074967
• 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: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 4234105
• Device Lot Number: REBW0616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR