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

Catalog Number 328468

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2018

Event Type  malfunction  

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 Description

It was reported after use of the bd insulin syringe with the bd ultra-fine¿ needle the consumer's daughter reported syringe needle missing from the syringe after she gave her mother the injection.She is not sure if the needle broke off inside of her mother's stomach, she thought it may have retracted back into the barrel.It was explained that the syringe is not retractable.No discomfort, pain or injury, does not intend to seek medical advice.Stated that her mother is (b)(6) yrs old and it is difficult to move her.¿ there was no report of further medical intervention.

Manufacturer Narrative

Investigation summary: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Device history record review ¿ a review of the device history record was completed for batch# 6326918.All inspections and challenges were performed per the applicable operations qc specifications.Syringe assembly ¿ there was one (1) batch of material# 700005657 (syringe 0.5ml asm 31g 8mm tw sm700178 sc) that went into the finished batch# 6326918.Batch# 7004863 date(s) of manufacture: 11jan2017 to 20jan2017.Machine(s) manufactured on: js, jq, jt, jy, jv.Needle assembly ¿ there were eleven (11) batches of material# 8006044 (needle sf asm 31ga 8mm tw orange) that went into the finished batch# 6326918.Batch# 7013899.Date(s) of manufacture: 18jan2017 to 20jan2017.Machine(s) manufactured on: needle line 10.Batch# 7010644.Date(s) of manufacture: 14jan2017 to 17jan2017.Machine(s) manufactured on: needle line 7.Batch# 7010642.Date(s) of manufacture: 13jan2017 to 18jan2017.Machine(s) manufactured on: needle line 10.Batch# 6350585.Date(s) of manufacture: 12jan2017 to 14jan2017.Machine(s) manufactured on: needle line 7.Batch# 6350584.Date(s) of manufacture: 08jan2017 to 08jan2017.Machine(s) manufactured on: needle line 10.Batch# 350583.Date(s) of manufacture: 06jan2017 to 08jan2017.Machine(s) manufactured on: needle line 10.Batch# 6350581.Date(s) of manufacture: 23dec2016 to 04jan2017.Machine(s) manufactured on: needle line 10.Batch# 337896.Date(s) of manufacture: 09dec2016 to 10dec2016.Machine(s) manufactured on: needle line 10 batch# 6319595.Date(s) of manufacture: 19nov2016 to 27nov2016.Machine(s) manufactured on: needle line 6.Batch# 6314967.Date(s) of manufacture: 15nnov2016 to 18nov2016.Machine(s) manufactured on: needle line 10.Batch# 6312577.Date(s) of manufacture: 14nov2016 to 15nov2016.Machine(s) manufactured on: needle line 10.There were twelve (12) notifications(b)(4) noted that did not pertain to the complaint.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 6326918.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.Based on the above, no additional investigation and 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.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7434281
• MDR Text Key: 105772702
• Report Number: 1920898-2018-00271
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 328468
• Device Lot Number: 6326918
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other