MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 4F DL MAX 3CG; 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	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refp0008 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc ecg wire tip broke off during insertion and is inside patient." additional information rcvd 06/28/2021 "no it has not been removed, and have not been notified of any pending procedures.".
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 break in the stylet was inconclusive due to the sample condition.One scanned image of the sherlock 3cg tcs graph was provided for investigation.The waveform was visible on both the external ecg line and on the intravascular ecg line.The stylet was not provided for investigation.Potential contributing factors of the reported break in the stylet include advancement against resistance, kinking, and retraction of the stylet through the extension set; however, since no evidence was provided to confirm the reported break, the complaint is inconclusive.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.H3 other text : device evaluation findings are in the manufacturer's note.
Event or Problem Description
It was reported "picc ecg wire tip broke off during insertion and is inside patient." additional information rcvd 06/28/2021 "no it has not been removed, and have not been notified of any pending procedures.".

• Brand Name: DOT PROV 4F DL MAX 3CG
• 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: 12182116
• Report Number: 3006260740-2021-02789
• Device Sequence Number: 17256831
• Product Code: LJS
• UDI-Device Identifier: 00801741130366
• UDI-Public: (01)00801741130366
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• 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): 08/12/2021

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: S1274108D
• Device Lot Number: REFP0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/01/2021
• 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