MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET (4; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	REDP2613
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a piece of metal being found within the picc was inconclusive due to the nature of the returned sample.The product returned for evaluation was one photograph which depicted a portion of 4fr s/l powerpicc solo catheter.The visible region of the catheter included the luer adapter, extension tubing and a portion of the molded joint.Usage residues were observed within the sample.The extension tubing appeared to contain fluid.No metal objects were discernible during inspection of the submitted photograph.Consequently this complaint is inconclusive at this time.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that there "appears to be a piece of metal stuck inside the picc lumen." no other information was provided.
Event or Problem Description
It was reported that there "appears to be a piece of metal stuck inside the picc lumen." 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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a piece of metal being found within the picc was confirmed to be manufacturing related.One 4 fr powerpicc solo catheter was returned for investigation.Blood residue was present on the catheter surface.The catheter extended up to the 18 cm depth marker.A solid tube was observed within the extension leg and moved around freely.The extension tubing was cut in order to remove the tube.The tube appeared to be a metal rod which measured 3.9 cm in length.Microscopic observation of the solo valve revealed no apparent damage.The present of the rod within the extension tubing indicates a manufacturing process may have contributed to the issue.Photos of the sample will be forwarded to the manufacturing facility for further evaluation.One photograph of a portion of 4fr s/l powerpicc solo catheter was also provided.The visible region of the catheter included the luer adapter, extension tubing and a portion of the molded joint.The photo corresponded with the returned physical sample.Reynosa evaluation.Complaint due to ¿piece of metal stuck inside the picc¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual, microscopical visual performed at vad lab it was concluded that the metallic rod piece founded inside the extension tubing was broken and left by mistake during the molding process.This condition makes the device unusable for our customer.Therefore, the cause of this condition is manufacturing related.As part of reinforcement about this issue, an awareness communication was provided to all personnel involved on this operation.A lot history review (lhr) of redp2613 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET (4
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8946758
• Report Number: 3006260740-2019-02530
• Device Sequence Number: 11516030
• Product Code: LJS
• UDI-Device Identifier: 00801741144684
• UDI-Public: (01)00801741144684
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: Health Professional
• Device Model Number: REDP2613
• Device Catalogue Number: CK000786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1