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

Catalog Number	305934
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone#: (b)(6).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 bd safetyglide¿ insulin syringe package didn't seal well, and the syringe was contaminated.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Customer returned (14) 1/2cc, 8mm, 30g bd safetyglide insulin syringes in open blister packs from lot # 8019988.Customer states that the package didn¿t seal well.All returned samples were examined and all exhibited an open seal along the side of the blister pack.Samples were forwarded to manufacturing (holdrege) on (b)(6) 2018 for further review.On (b)(6) 2018, holdrege received fourteen (14) 0.5ml, 8mm, 30g bd safetyglide insulin syringes in open blisterpacks from batch# 8019988.All samples were decontaminated per hstr-17 and hqa-68 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.The returned samples were visually inspected and noted the bottom web to be marked with lane/position identifier "j 5".This type of identification stamp are utilized within the manufacturing process in order to maintain trackability/traceability of the individual devices packaged on the line.The stamp noted on the returned samples represents an outer lane on the packaging equipment.Given the defect noted, this appears to be an alignment issue during the sealing and cutting of the individual blisterpacks.When this occurs, the top and bottom web is not aligned properly so that when the individual blisters are formed from the cut, it impedes the seal(s) in the process.While unusual, this type of event can occur either during a jam or when the equipment is placed into a "jog" functionality to try to realign materials.A review of the device history record was completed for batch# 8019988.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 3rd related complaint for open package/seal (blister pack) on lot # 8019988.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.
Event or Problem Description
It was reported that bd safetyglide¿ insulin syringe package didn't seal well, and the syringe was contaminated.No serious injury or medical intervention was reported.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8067863
• Report Number: 1920898-2018-00869
• Device Sequence Number: 19403070
• Product Code: FMF
• UDI-Device Identifier: 00382903059348
• UDI-Public: 382903059348
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K992734
• 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): 12/12/2018

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: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 305934
• Device Lot Number: 8019988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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