MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number 381834

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte autoguard pnk 20ga x 1.16in there was a mixture of products in one pack.There was no report of patient impact.The following information was provided by the initial reporter: during an in-process control in production (ipc every 30 minutes) on (b)(6) 2022 the operator found a mix-up between batch 2109740 (supplier's batch) and batch 2112426.Some product from batch 2112426 were found inside the batch 2109740.200 mixed catheters were found during the sort.Additionally, a previous reclamation concerning a mix-up of this product was sent the (b)(6) 2021.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photos of 20ga x 1.16in insyte autoguard units.The photos display the units in a box from lot number 2112426.Based on the description of your report, these are the units that got mixed with product from lot number 2109740.The material number is the same.The reported issue was confirmed.Mixed lots may occur during manufacturing or packaging due to improper line clearance by operators or an improper line purge due to equipment software error.Operators also perform periodic visual inspections per the quality plan to mitigate the occurrence of this defect.The distribution center was contacted to find where the lots may have been mixed at.The distribution list records that "delpharm evreux" was only supposed to receive units from lot number 2109740.There is no record of lot number 2112426 being shipped to them.Since there is photo evidence of the lot number 2112426 being present in their facility this defect is confirmed.The mixed product likely occurred within bd control and may have occurred during packaging or in the distribution center.There was no evidence of mislabeling or that lots were mixed within the shipper boxes.A device history record review showed no non-conformances associated with this issue during the production of these batches.

Event Description

It was reported while using bd insyte autoguard pnk 20ga x 1.16in there was a mixture of products in one pack.There was no report of patient impact.The following information was provided by the initial reporter: during an in-process control in production (ipc every 30 minutes) on november 23rd, 2022 the operator found a mix-up between batch 2109740 (supplier's batch) and batch 2112426.Some product from batch 2112426 were found inside the batch 2109740.200 mixed catheters were found during the sort.Additionaly, a previous reclamation concerning a mix-up of this product was sent on the 22/09/2021.

• Brand Name: BD INSYTE AUTOGUARD PNK 20GA X 1.16IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15996940
• MDR Text Key: 308162923
• Report Number: 1710034-2022-00817
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: (01)00382903818341
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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
• Device Operator: Other
• Device Model Number: 381834
• Device Catalogue Number: 381834
• Device Lot Number: 2109740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1