MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE PLUS¿ PEN NEEDLE

Catalog Number 320136

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd micro-fine plus¿ pen needle 30gx8mm was found in a package of 32gx4mm pen needles.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: three photos of a 32g x 4mm pen needle polybag from lot.No.6348600 and one loose pen needle sample from lot.No.6327527 were returned for analysis.Visual examination was carried out and it was observed that one 30g pen needle sample from lot.No.6327527 was mixed in a 32g x 4mm pen needle polybag from lot.No.6348600.A lot history review was carried out and one related nonconformance was raised in association with lot.No.6348600.Lot.No.6348600 was manufactured on line 14, january 18th to 22nd, 2017 and packaged on line 667 january 29th to february 04th, 2017.Lot.No.6327527 was manufactured on line 1 january 22th to 25th 2017 and packaged on line 655 january 30th, 2017.On investigation a product spill occurred beside the (b)(6) work in progress (wip) storage area.Pen needles from lot.No.6327527 were spilled in the area adjacent to storage of pallets of lot.No.6348600.The effected product from the spill was cleared and scrapped in the area where the spill occurred however the adjacent pallets of lot.No, 6348600 were not inspected for rogue parts.Product for japan packaging is packed into plastic totes with a lid which seals the tote.This prevents ingress of pen needles into the tote.During loading of lot.No.6348600 in japan packaging area the operator identified five pen needles from lot.No.6327527 on pallets of lot.No.6348600 queued up to be packed.The loose pen needles were found between totes on the pallets.A full inspection was carried out of all pallets and no further defects were identified.The most probable root cause for the spill was due to incorrect stacking of the totes on the pallet and when the pallet was moved the tote fell over, thereby exposing product.On inspection of the totes of lot.No.6348600 a loose pen needle was inadvertently trapped between totes and was loaded into the good product chute which feeds the packaging machine.100% inspection of pallets and totes were carried out on lot.No.6348600.Line clearance was performed in (b)(6) packaging at the time of discovery.No further defects were discovered.Sampling on the lot was carried out and no further defects were identified.Lots are no longer staged in close contact with each other and are staged separately for (b)(6) packaging.All (b)(6) product when palletized are now shrink wrapped at the assembly line and shrink wrapping is only removed when the pallet is to be loaded onto the (b)(6) packaging line hoppers.This is to mitigate risk of any potential mix.

Event Description

It was reported that bd micro-fine plus¿ pen needle 30gx8mm was found in a package of 32gx4mm pen needles.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD MICRO-FINE PLUS¿ PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 7865597
• MDR Text Key: 120105603
• Report Number: 9616656-2018-00181
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 320136
• Device Lot Number: 6348600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Date Manufacturer Received: 08/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other