MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

Catalog Number	326730
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.A sample is not available for evaluation.However, a no sample investigation will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the consumer received bd¿ insulin syringe with bd ultra-fine¿ needle(s) that were not sealed and seemed to be tampered with.The product was not used and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
The initial mdr was submitted with an unknown lot number.Mdr device information, including lot number, has been updated according to samples received.Upon completion of the investigation, another supplemental report will be filed.Add¿l information: lot # provided: 6335702, medical device expiration date: 01/31/2022 and device manufacture date: 11/30/2016.
Additional Manufacturer Narrative
Investigation summary: two investigations were carried out.First investigation summary: customer returned (3) 1/2cc, 6mm, 31g u500 insulin syringes in blister packs from lot # 6335702.Customer states that the bag was not sealed and seemed to be tampered with.All returned samples were examined and all exhibited an open blister pack with broken pieces of other syringes in the blister packs.Samples were forwarded to manufacturing (holdrege) on 06apr2018 for further investigation.Second investigation summary: on (b)(6)2018 , holdrege received three (3) 0.5ml, 6mm, 31g u-500 syringes in opened blister-packs from batch# 6335702.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah and qe jh, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.A review of the device history record was completed for batch# 6335702.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200681721] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 6335702.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Probable root cause is likely to be a jam along the separation blade, resulting in incomplete seals/cuts when separating the individual blister-packs during production.If the jam is not cleared in a timely manner, this can lead to open blister-packs and/or syringes being caught within the seal of the blister-pack, such as is observed within the returned samples.Based on the above, no capa is required at this time.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.

• Brand Name: BD¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7345743
• Report Number: 1920898-2018-00128
• Device Sequence Number: 84374
• Product Code: FMF
• UDI-Device Identifier: 00382903267309
• UDI-Public: 00382903267309
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 05/21/2018

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 Expiration Date: 01/31/2022
• Device Catalogue Number: 326730
• Device Lot Number: 6335702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 02/22/2018; 02/22/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/23/2018; 05/22/2018
• 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