MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION¿ INSULIN SYRINGE

Catalog Number	328505
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that two of the bd relion¿ insulin syringes had shields missing and were lying on the bottom of the bag.Found before use.No serious injury or medical intervention noted.
Additional Manufacturer Narrative
Severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defects/conditions on lot number 6284901.A review of the device history record was completed for batch # 6284901.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200667632] noted that did not pertain to the complaint.Two investigations were performed.First investigation summary: customer returned (7) 1cc, 8mm, 30g relion syringes in an open poly bag from lot # 6284901.Customer states that the shield was missing and lying at the bottom of the bag.Two syringes were returned with the hub-needle/shield separated from the barrel.Both barrels were examined and both exhibited a broken barrel tip.Also, all samples exhibited a crushed plunger cap.Samples were forwarded to manufacturing (holdrege) on 16feb2018 for further review.On 23feb2018 holdrege received seven (7) 1ml, 8mm, 30g relion syringes in an opened polybag from batch# 6284901.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation in bd (b)(4) were noted.Probable root cause is likely to be damage during packaging.When this occurs, any component and/or portion of the syringe may be affected and make its way to the consumer.Bd was able to duplicate or confirm the customer¿s indicated failure (broken barrel tip and crushed plunger cap).Possible root cause for broken barrel tip is that it can be caused by the tamping of the packages within the carton to allow closure of the carton.Possible root cause for crushed plunger cap: the syringe was caught in the sealing bars of the packaging machine, crushing the cap.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no capa is required at this time.

• Brand Name: RELION¿ INSULIN SYRINGE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7232651
• Report Number: 1920898-2018-00018
• Device Sequence Number: 19331335
• Product Code: FMF
• UDI-Device Identifier: 00681131311687
• UDI-Public: 00681131311687
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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: Lay User/Patient
• Device Catalogue Number: 328505
• Device Lot Number: 6284901
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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