MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD U-100 INSULIN SYRINGE SLIP TIP WITH PRECISIONGLIDE¿ NEEDLE; INSULIN SYRINGE WITH NEEDLE

Catalog Number	326730
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
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.
Event or Problem Description
It was reported that a consumer found the barrel cracked on a bd u-100 insulin syringe slip tip with precisionglide¿ needle prior to use.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 6006684.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) batches of material# 700007097 (syringe 0.5ml asm bls 31g 6mmtw sm700171) that went into the finished batch# 6006684.Batch# 6319594 was manufactured 21nov2016 to 27nov2016.Batch# 6260547 was manufactured 22sep2016 to 09oct2016.There were eight (8) notifications [200658443, 200658830, 200667259, 200657947, 200658442, 200658388, 200658829, 200667601] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 2nd related complaint for cracked barrel and the 1st related complaint for incorrect count (less) on lot # 6006684.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD U-100 INSULIN SYRINGE SLIP TIP WITH PRECISIONGLIDE¿ NEEDLE
• Common Device Name: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7538958
• Report Number: 1920898-2018-00343
• Device Sequence Number: 1318197
• Product Code: FMF
• UDI-Device Identifier: 00382903267309
• UDI-Public: 00382903267309
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151870
• 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): 05/25/2018

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: 03/31/2021
• Device Catalogue Number: 326730
• Device Lot Number: 6006684
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 05/25/2018
• 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