MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; MIDLINE CATHETER

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reer0574 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reer0574) have been reported from the same facility.

Event Description

On (b)(6) 2020 "a virtual demonstration of provena picc kits was provided to vascular access nurses at hospital.Samples of a 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.

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 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 reer0574 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (reer0574) have been reported from the same facility.

Event Description

7/13/2020 "a virtual demonstration of provena picc kits was provided to vascular access nurses at hospital.Samples of a 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.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10376773
• MDR Text Key: 202055323
• Report Number: 3006260740-2020-02822
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154164
• UDI-Public: (01)00801741154164
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REER0574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1