MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE; 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	05/31/2022
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 refw2433 showed no other similar product complaint(s) from this lot number.Device not returned.
Event or Problem Description
It was reported during the jejunostomy procedure, according to the surgeon's report, when inserting the picc catheter, 3 microholes were observed at the proximal end of the catheter.
Event or Problem Description
It was reported during the jejunostomy procedure, according to the surgeon's report, when inserting the picc catheter, 3 microholes were observed at the proximal end of the catheter.
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 catheter is confirmed.One 3 fr single lumen per-q-cath was returned for evaluation.An initial visual observation showed use residue on the returned sample.A t-lock was returned on the hub of the catheter, and no stylet was returned within the t-lock or catheter.The returned sample was flushed with a 12 ml syringe of water and spraying leaks were observed in the catheter just distal to the strain relief and between the 0 cm and 1 cm depth markers.A microscopic observation revealed three relatively large splits in the catheter tubing at the location of the leaks.These splits were observed to be slightly curved with rough edges.The split at the distal end of the strain relief was observed to be larger than the other two splits and a consistent striated pattern was observed on the surfaces of this split.Abrasive damage was observed on the inner wall of the catheter at the corners of the largest split and the split was observed to be longer on the interior side of the split than the exterior, indicating the damage originated from the interior of the catheter.The shape, texture, and location of the split as well as the abrasive damage observed on the interior of the catheter tubing indicate the catheter was likely damaged due to excessive friction from the internal stiffening stylet.As a note, the stylet must be properly hydrated prior to movement or manipulation of the stylet within the catheter.H3 other text : evaluation findings are in section h.11.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15385058
• Report Number: 3006260740-2022-03519
• Device Sequence Number: 20260672
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REFW2433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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