MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 3GAL RECYKLEEN PEARL; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305053
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Oem manufacture: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that 2 sharps coll 3gal recykleen pearl experienced a missing lid or slide lid/clamp which was noted prior to use.The following information was provided by the initial reporter: material no: 305053 ; batch no: 8288916.Verbatim: had customer complain that they were shorted 2 lids for these sharps containers.
Additional Manufacturer Narrative
H.6.Investigation summary: it was reported that 2 lids were missing.A sample and photo representation was provided for evaluation.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance reported for missing lids for the same part number.No additional complaints were received for the last twelve months for the same part number and issue.As part of this investigation it was noticed that this complaint came up from parts sold by a distributor.There may have potentially been a repackaging issue which occurred during distribution.The actual root cause is unknown.Based on these findings, our investigation is inconclusive.Bd will continue to monitor for any trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that 2 sharps coll 3gal recykleen pearl experienced a missing lid or slide lid/clamp which was noted prior to use.The following information was provided by the initial reporter: material no: 305053; batch no: 8288916.Verbatim: had customer complain that they were shorted 2 lids for these sharps containers.

• Brand Name: SHARPS COLL 3GAL RECYKLEEN PEARL
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8899374
• Report Number: 2243072-2019-01731
• Device Sequence Number: 16826892
• Product Code: FMI
• UDI-Device Identifier: 50382903050531
• UDI-Public: 50382903050531
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

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: 305053
• Device Lot Number: 8288916
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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