MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F W/STIFFENING STYLET WIRE (SL) (65 CM); 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when performing the catheter washing test prior to access puncture, the team observed the presence of leakage and evidenced that the catheter was damaged.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeq3692 showed six other similar product complaint(s) from this lot number.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed.The product returned for evaluation was one 3fr s/l per-q-cath catheter.The sample was received with an inlaid stylet.The catheter appeared bunched/curved near the suture wing.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, two leaks were observed near the suture wing.Tactile inspection of the sample revealed tensile weakness, necking and material discoloration in the vicinity of the leaks.Microscopic inspection of the leak sites revealed two diagonally aligned splits.The split exhibited granular fracture surfaces.Following longitudinal bisection of the sample in the vicinity of the splits, inspection of the inside surface revealed scoring marks and abrasion damage at the split sites.The damage on the inside surface was more extensive than that observed on the outside surface of the catheter wall.The catheter bunching, split features and tensile weakness were consistent with damage caused by traumatic contact between the catheter material and the stylet.Such damage can occur if stylet removal/manipulation is attempted prior to flushing the catheter and if the stylet is removed/manipulated when the catheter is pinched or otherwise constrained.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported when performing the catheter washing test prior to access puncture, the team observed the presence of leakage and evidenced that the catheter was damaged.

• Brand Name: PER-Q-CATH PLUS PICC 3F W/STIFFENING STYLET WIRE (SL) (65 CM)
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13025264
• Report Number: 3006260740-2021-05356
• Device Sequence Number: 11993514
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844
• 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
• Report Date (Section B): 08/10/2022

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REEQ3692
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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 Sex: Unknown