MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 6F RADIOLOGY BASIC TRAY DL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3276135
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
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 redz1560 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that patient has a picc inserted.Error in the guidewire measurement marking, it was reversely imprinted.Marking was supposed to be imprinted starting from the tip of the guidewire, however, marking was imprinted starting on the back end of the wire instead.
Event or Problem Description
It was reported that patient has a picc inserted.Error in the guidewire measurement marking, it was reversely imprinted.Marking was supposed to be imprinted starting from the tip of the guidewire, however, marking was imprinted starting on the back end of the wire instead.
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 lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of incorrect guidewire depth markings is confirmed and appears to be supplier related.One 135 cm guidewire was returned for evaluation.The proximal and distal end of the guidewire were observed to contain bends.An inspection of the guidewire print markings revealed the first markers to be located 34.5 cm from the distal end (floppy tip) and 19.5 cm from the proximal end.A product packaging label was also returned with product information indicating ref:3276135 and lot: redz1560.The start and ending locations of the guidwire depth markers appear to be oriented backwards.Additional review of the photos of the sample by the manufacturing facility confirmed the incorrect printing on the guidewire; therefore, the complaint is confirmed, supplier related.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY DL
• 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: 10793498
• Report Number: 3006260740-2020-20398
• Device Sequence Number: 558865
• Product Code: LJS
• UDI-Device Identifier: 00801741028007
• UDI-Public: (01)00801741028007
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K051991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: Other
• Device Expiration Date: 11/30/2023
• Device Model Number: 3276135
• Device Catalogue Number: 3276135
• Device Lot Number: REDZ1560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 01/08/2021
• 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