MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 17GAL YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305614
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 has been reported that the sharps coll chemo 17gal yellow has been found missing lids before use.The following has been provided by the initial reporter: it was reported that customer received case of containers missing the lids.Per customer email: stated that the customer received 1 cas of the containers minus lids.Material #: 305614, lot #: 9127916 , quantity: 1 case, issue with lid ¿ (example: missing lid, cracked, broken): missing lids.
Additional Manufacturer Narrative
H.6.Investigation summary: it was reported that lids were missing.No sample or photo representation was provided for evaluation.No photo of the original packaging was provided.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.This lot was confirmed produced after corrective actions.A weight system that provides a weighted label for each final box before shipment has already been implemented for this product to ensure the correct quantity of pieces per box before shipping.It was not possible to confirm that any failure mode was related to the manufacturing process with the information provided since the weight system is validated and did not detect any missing components.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 has been reported that the sharps coll chemo 17gal yellow has been found missing lids before use.The following has been provided by the initial reporter: it was reported that customer received case of containers missing the lids.Per customer email: stated that the customer received 1 cas of the containers minus lids.Material #: 305614, lot #: 9127916, quantity: 1 case, issue with lid ¿ (example: missing lid, cracked, broken): missing lids.

• Brand Name: SHARPS COLL CHEMO 17GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8843022
• Report Number: 2243072-2019-01533
• Device Sequence Number: 19208604
• Product Code: FMI
• UDI-Device Identifier: 50382903056144
• UDI-Public: 50382903056144
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 09/04/2019

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: 305614
• Device Lot Number: 9127916
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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