MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
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 redz1548 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redz1548) have been reported from the same facility.
Event or Problem Description
It was reported: "a virtual demonstration of provena picc kits was provided to vascular access nurses at hospital.Samples of 4fr provena picc kit were provided.During discussion nurses and bd cs noticed that pieces of gt needle guide plastic fragmented off as insertion needle was inserted into each of the needle guides.Several nurses attempted using the gt needle guides with the same result of plastic shearing off the center of the needle guide.This is a potential patient care complication because the plastic could become an emboli in the patients blood stream." this occurred with three kits.This report addresses the third kit.
Event or Problem Description
It was reported: "a virtual demonstration of provena picc kits was provided to vascular access nurses at hospital.Samples of 4fr provena picc kit were provided.During discussion nurses and bd cs noticed that pieces of gt needle guide plastic fragmented off as insertion needle was inserted into each of the needle guides.Several nurses attempted using the gt needle guides with the same result of plastic shearing off the center of the needle guide.This is a potential patient care complication because the plastic could become an emboli in the patients blood stream." this occurred with three kits.This report addresses the third kit.
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 needle guide damage during attempted use was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one set of 21ga pinpoint needle guides.All four guides appeared to be deformed.Microscopic inspection of the guides revealed gouges and needle damage.The needle pathway appeared to be uneven.The proximal ends of the guides appeared to be deformed/compressed.An unused non-complainant needle was inserted through each of the four guides.Resistance was encountered and the needle tip was observed to shave pieces of plastic from the guide in all four cases, resulting in plastic debris accumulating at the distal end of the guide.Material debris were generated regardless of needle orientation.The same needle was inserted through unused non-complainant needle guides.Insertion was unremarkable and no plastic debris was observed.The needle guide damage caused by the needle appeared to have been caused by uneven needle pathways due to guide deformation.Such deformation may be the result of molding, curing and storage conditions.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.Reynosa evaluation complaint due to ¿pieces of gt needle guide plastic fragmented off¿ was confirmed.According with the photo evaluation performed at reynosa facility and vad field assurance evaluation the following was concluded: a deformation was found to be on the guides leading an uneven needle pathway.This condition caused resistance while passing the needle through the guide and resulted in plastic debris accumulating at the distal end of the guide as consequence.This condition may have been potentially caused during manufacturing process at supplier facility.Therefore, the cause of this condition is supplier related.An incident report was issued to notify our supplier about this issue.A lot history review (lhr) of redz1548 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (redz1548) have been reported from the same facility.

• Brand Name: 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10378393
• Report Number: 3006260740-2020-02842
• Device Sequence Number: 13999753
• Product Code: PND
• UDI-Device Identifier: 00801741154164
• UDI-Public: (01)00801741154164
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S4254108BDP
• Device Lot Number: REDZ1548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1