MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV 4F TLS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9274108D
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/12/2020
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 reer3431 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a kit had very rusted scissors.No other information was provided.Additional information received 11/05/2020: it was reported the picc was not used and discarded upon discovering the rusted equipment prior to trimming the picc, but the needle, wire, and dilator from the kit were used.
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 rust on the scissors is confirmed and appears to be supplier related.One pair of scissors was returned for evaluation.A written note was also provided with the product sticker label attached and indicated lot: reer3431.The note states, ¿scissors rusted¿.Rust was visible on the inner and outer facing sides of the blades.One photo of scissors and a product sticker label attached to a written note was also provided for evaluation.The scissors are shown in their open position.Orange-brown discoloration is visible on the blade surfaces.The components shown in the photo correspond with the returned physical sample.The photos of the sample were forwarded to the manufacturing facility.The manufacturing evaluation confirmed the presence of corrosion on the scissor blades and determined the cause to be supplier related.The supplier was notified of the event.H3 other text.
Event or Problem Description
It was reported a kit had very rusted scissors.No other information was provided.Additional information received 11/05/2020: it was reported the picc was not used and discarded upon discovering the rusted equipment prior to trimming the picc, but the needle, wire, and dilator from the kit were used.

• Brand Name: POWERPICC SV 4F TLS
• 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: 10877286
• Report Number: 3006260740-2020-20600
• Device Sequence Number: 1154312
• Product Code: LJS
• UDI-Device Identifier: 00801741035678
• UDI-Public: (01)00801741035678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• 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): 12/22/2020

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: 09/30/2021
• Device Model Number: 9274108D
• Device Catalogue Number: 9274108D
• Device Lot Number: REER3431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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