MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER 4F MBTRAY W/ MI SL SHERLOCK; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reez3474 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported customer opened the tray and the filter stray for the lidocaine had some type of brown/black goop inside the filter straw.No other information was provided.
Event or Problem Description
It was reported customer opened the tray and the filter stray for the lidocaine had some type of brown/black goop inside the filter straw.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, 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 foreign material is confirmed.One filter straw accessory component was returned for evaluation.A dark, brownish material is visible within the clear tubing.The clear tubing was cut in order to inspect the material.The material appeared to be a resin-like material.Photos of the sample were forwarded to the manufacturing facility for further review and found the material to have likely been introducer during the manufacturing process.Since the affected device is a supplied component, the complaint is confirmed.Bd is working closely with the supplier to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC SOLO2 CATHETER 4F MBTRAY W/ MI SL SHERLOCK
• 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: 11826258
• Report Number: 3006260740-2021-01867
• Device Sequence Number: 11804066
• Product Code: LJS
• UDI-Device Identifier: 00801741035609
• UDI-Public: (01)00801741035609
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 08/19/2021

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 Model Number: N/A
• Device Catalogue Number: 9194108D
• Device Lot Number: REEZ3474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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