MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SL SAFETY INTRODUCER BT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the stylet wire was elongated was confirmed but the cause is unknown.A series of photographs were returned for evaluation of this complaint.Two photos were of the opened tray of a 4fr s/l per-q-cath catheter kit.The catheter appeared to have been trimmed at the 50cm depth marking but was otherwise unremarkable.The t-lock assembly had been detached from the catheter luer adaptor and the stylet had been removed from within the catheter lumen.The braided stylet was unraveled and elongated.Multiple bends were seen in the wire and it was tangled upon itself.Although it could be confirmed that the wire had become damaged, the exact root cause could not be determined from the photographs.Possible contributing factures could include a damaged hydrophilic coating, failure to hydrate stylet prior to removal, the stylet kinking prior to removal, or the stylet being damaged while trimming the catheter.The warning tag attached to the device states, ¿warning-flush catheter prior to use-catheter stylet with hydrophilic coating.¿ and ¿warning-do not cut stylet-withdraw stylet before trimming catheter.¿ manufacturing documents for this lot/batch were reviewed and no deviations or issues were identified that would have contributed to the reported event.A lot history review (lhr) of reeq2451 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after the package was opened, the customer found that the guide wire had been pulled out.(b)(6) 2022: the returned stylet was found unraveled and elongated with multiple bends and had tangled upon itself.

• Brand Name: PER-Q-CATH PLUS 4F SL SAFETY INTRODUCER BT
• 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: 13373928
• Report Number: 3006260740-2022-00100
• Device Sequence Number: 3679559
• Product Code: LJS
• UDI-Device Identifier: 00801741074899
• UDI-Public: (01)00801741074899
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

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 Model Number: N/A
• Device Catalogue Number: 4134115
• Device Lot Number: REEQ2451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/27/2022
• 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