MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 3F SL PICC BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	7715305
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redy1679 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the proximal end of the guide wire was found detached before the product was used.The operator opened a new kit for puncture in the patient.
Event or Problem Description
It was reported that the proximal end of the guide wire was found detached before the product was used.The operator opened a new kit for puncture in 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, 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 damaged guidewire was confirmed.The product returned for evaluation was one guidewire in its plastic hoop.Blood residue was observed throughout the distal region of the needle.Curved shape memory was observed near the distal tip.The core wire was broken off of the distal weld tip and tip of the core wire protruded from the coil wire.The weld tip was bent, but remained attached to the coil wire.Tactile inspection of the sample confirmed that the coil wire was intact.Microscopic inspection of the sample confirmed blood residue in the vicinity of the core wire break.The break surface exhibited a granular fracture surface.Necking was observed in the vicinity of the break.The break features were consistent with a tensile break.The curved shape memory suggested that initial insertion against resistance may have deformed the guidewire, leading to resistance during removal, leading to a break in the core due to pulling stress.The blood residue suggested that deformation and resistance occurred during device use.H3 other text : evaluation findings are in section h.11.

• Brand Name: GROSHONG 3F SL PICC BASIC TRAY
• 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
• MDR Report Key: 11876561
• Report Number: 3006260740-2021-01996
• Device Sequence Number: 11677714
• Product Code: LJS
• UDI-Device Identifier: 00801741035289
• UDI-Public: (01)00801741035289
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 7715305
• Device Catalogue Number: 7715305
• Device Lot Number: REDY1679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other