MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT STC PPICC, SOLO, 5FR; 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	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reey2939 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there are stylet issues.Additional information received 5/5/2021: it was reported on (b)(6) that the stylet was broken.The broken piece remains in the patient's axilla and has been determined to be irretrievable.It was stated that the picc felt resistance when threading and that the insertion had to be aborted.The stylet wire was checked and it was noted that 1cm of the stylet tip was missing and was unable to be found in the sterile field.An x-ray was performed and the missing piece was found in the patient's hemithorax.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged 3cg stylet was confirmed, but the exact cause could not be determined.One 3cg stylet was returned for investigation.The stylet exhibited evidence of use and had been removed from the picc.A complete break in the magnet tip was confirmed and the broken segment was not returned.Microscopic examination of the fracture region revealed kinking between the magnet joints and the break appeared to be located at the end of a magnet.No potential manufacture damage, defect, or deformity was seen on the sample.The polyimide tubing was confirmed to be within manufacture specification.The observed fracture features were indicative of catheter and/or stylet kinking and likely occurred during the insertion process.However, the exact circumstances providing for that type of event were ultimately unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that there are stylet issues.Additional information received 5/5/2021: it was reported on on (b)(6) that the stylet was broken.The broken piece remains in the patient's axilla and has been determined to be irretrievable.It was stated that the picc felt resistance when threading and that the insertion had to be aborted.The stylet wire was checked and it was noted that 1cm of the stylet tip was missing and was unable to be found in the sterile field.An x-ray was performed and the missing piece was found in the patient's hemithorax.

• Brand Name: DOT STC PPICC, SOLO, 5FR
• 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: 11866698
• Report Number: 3006260740-2021-01953
• Device Sequence Number: 19730349
• Product Code: LJS
• UDI-Device Identifier: 00801741085727
• UDI-Public: (01)00801741085727
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 1395118Q
• Device Lot Number: REEY2939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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: Required Intervention