MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿ HYPODERMIC NEEDLE

Catalog Number	300255
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8255230, medical device expiration date: 2023-09-30, device manufacture date: 2018-11-23.Medical device lot #: 8255229, medical device expiration date: 2023-09-30, device manufacture date: 2018-11-06.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd hypoint¿ hypodermic needle had incorrect label information.There are two labels with two different batch numbers, 8255230 and 8255229.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
H.6.Investigation: 5 picture evidences were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during supply process and quality inspections.This review did identify a non-conformance related to the reported condition: the quantities filled in the shipping documents do not match the packing list and this discrepancy was not identified as there was no quantity reconciliation.The additional box labels were swapped and added to the wrong boxes, resulting in batch number mismatch between box manufacturing labels and box additional labels.Root cause can mainly be attributed to process organization, with lack of segmentation in work operations and labelling operations that are not processed one at a time.In addition, due to the start phase of the distribution center ceva and recent hired operators, the lack of experience during emergency periods led to the detriment of quality controls.Bdm-ps can confirm that the mix up only concerns the additional box labels and that the manufacturing box labels are conform.Following the official material quality complaint #(b)(4) raised to the bd distribution center ceva, work operations are now segmented and each label printed must be stuck on the pallet one at a time before moving forward with the rest of the labels printing.Finally, a training session was conducted with controllers and a new associate was added to the team to better respond during emergencies.
Event or Problem Description
It was reported that bd hypoint¿ hypodermic needle had incorrect label information.There are two labels with two different batch numbers, 8255230 and 8255229.No serious injury or medical intervention was reported.

• Brand Name: BD HYPOINT¿ HYPODERMIC NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8311155
• Report Number: 8041187-2019-00136
• Device Sequence Number: 16194522
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K070440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 300255
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other