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

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refp4336 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when delivering the guide wire during picc insertion, resistance was encountered.The guide wire could not be delivered further nor withdrawn.When attempting to relax the vessel for continued withdrawal, the guide wire was ruptured.

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: sample analysis, patient severity, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed.The products returned for evaluation were one 0.018 in.Nitinol guidewire, one 3 fr clearvue groshong catheter with a stylet and flushing hub inserted, one proximal 3 fr groshong connector piece, and one silicone injection cap.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product sample was evaluated, and the guidewire was confirmed to be broken which allowed the outer coil wire to become unraveled.Microscopic examination of the fracture sites revealed the following: ¿ shearing of the wire at the break which was indicative of direct contact with a hard-edged instrument (such as an introducer needle) ¿ narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire ¿ the weld tip of the wire was missing and could not be accounted for during the evaluation normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.

Event Description

It was reported that when delivering the guide wire during picc insertion, resistance was encountered.The guide wire could not be delivered further nor withdrawn.When attempting to relax the vessel for continued withdrawal, the guide wire was ruptured.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY W/SAFETY INTRODUCER
• Type of Device: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16075338
• MDR Text Key: 306406249
• Report Number: 3006260740-2022-05932
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K926331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 7717305
• Device Lot Number: REFP4336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention