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

Model Number	CK000631B
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reet2026 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that probe cover was removed from the packaging and had a slit.No other information was provided.
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 review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a slit in the probe cover is confirmed but the exact cause remains unknown.Two photo samples were provided for evaluation.The first photo sample showed a probe cover over a probe device.A horizontal split in the probe cover was visible.The edges from split could not be clearly inspected; however, the split appeared to have a clean cut near the center but uneven near the ends.The second image showed the product label sticker which indicated lot: reet2026.Based on the condition of the sample shown in the images, possible contributing factors include sharp instrument damage and damage prior to kit packaging; however, a review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Since the condition of the probe cover prior to kit opening and use is unknown, the source of the damage could not be determined; therefore, the complaint is confirmed, cause unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that probe cover was removed from the packaging and had a slit.No other information was provided.

• Brand Name: POWERPICC 3CG 3F SL
• 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: 10906898
• Report Number: 3006260740-2020-20676
• Device Sequence Number: 545398
• Product Code: LJS
• UDI-Device Identifier: 00801741143748
• UDI-Public: (01)00801741143748
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 12/16/2020

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: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: CK000631B
• Device Catalogue Number: CK000631B
• Device Lot Number: REET2026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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