MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regt3274 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the clinician "i accessed the vein with the needle.Had blood dripping out of it.Started to put the wire in.Could feel it like dragging against the needle going in, that feel always tells me i¿m in the vein.Started advancing the wire, it stopped.So i tried pulling the wire out, would not come out.Thought it may be caught on the needle tip so i pulled the needle and the wire, needle came out, wire stayed in.The pa call the surgeon he said anchor it and put bacitracin on it, he¿ll take care of it in the morning.While they were getting things i was pulling back gently and i felt it give, though i had it.Looked under my gauze and that¿s what i saw, it completely uncoiled.The patient is going to or to have it removed and have a central line placed.I asked if patient moved or had flabby arms.No didn¿t move that i could tell, firmer arm.No this felt like it was going in the vein.Usually if it¿s in the tissue can se the skin movement.I watch for that too the wire was removed.The report indicated the wire was in the vein, and it uncoiled on the way in.
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 batch history, applicable previous investigation(s), applicable manufacturing records, photo sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a frayed guidewire is confirmed but the exact cause remains unknown.One photo sample of a guidewire was provided for evaluation.The guidewire is shown to be inserted within the patient and the needle is not visible.The guidewire is shown to be frayed with an elongated coil wire.The core wire is curved; however, the distal tip could not be closely inspected.The characteristics of the introducer needle and guidewire could not be closely inspected from the image provided.Based on the information provided, possible contributing factors include retraction of the guidewire against the needle bevel, guidewire kinking, and retraction against resistance.Since the guidewire was observed to be frayed within the patient, the complaint is confirmed, but the exact factors contributing to the issue remain unknown.A review of the manufacturing records did not reveal any evidence to suggest that a manufacturing related root cause contributed to the reported event.
Event or Problem Description
It was reported by the clinician "i accessed the vein with the needle.Had blood dripping out of it.Started to put the wire in.Could feel it like dragging against the needle going in, that feel always tells me i¿m in the vein.Started advancing the wire, it stopped.So i tried pulling the wire out, would not come out.Thought it may be caught on the needle tip so i pulled the needle and the wire, needle came out, wire stayed in.The pa call the surgeon he said anchor it and put bacitracin on it, he¿ll take care of it in the morning.While they were getting things i was pulling back gently and i felt it give, though i had it.Looked under my gauze and that¿s what i saw, it completely uncoiled.The patient is going to or to have it removed and have a central line placed.I asked if patient moved or had flabby arms.Answer - no didn¿t move that i could tell, firmer arm.No this felt like it was going in the vein.Usually if it¿s in the tissue can se the skin movement.I watch for that too the wire was removed.The report indicated the wire was in the vein, and it uncoiled on the way in.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• 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: 16200269
• Report Number: 3006260740-2023-00059
• Device Sequence Number: 11875590
• Product Code: LJS
• UDI-Device Identifier: 00801741143755
• UDI-Public: (01)00801741143755
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000632B
• Device Lot Number: REGT3274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: Required Intervention
• Patient Sex: Unknown