MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1ML, 31G X 6MM BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; INSULIN SYRINGE AND NEEDLE

Catalog Number 324912

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

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

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.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 that 1ml, 31g x 6mm bd insulin syringe with the bd ultra-fine¿ needle broke off on three different syringes.Found during use.No serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: date: 15nov2017, from: (b)(6), defect: needle break off du, cat.#: 324912, batch#: 7128822, product description: syringe 1.0ml 31ga 6mm 10bag 500cs.Date(s) of packaging: 18jun2017 thru 20jun2017, machine(s) packaged on: (b)(4).Device history record review ¿ a review of the device history record was completed for batch# 7128822.All inspections were performed per the applicable operations qc specifications.A sample or photo was not available for evaluation; therefore, the investigation was limited.A review of the manufacturing records was performed for the incident lot and no issues were identified.Assembled syringe- there was one (1) batch of material# 700003982 (syringe 1.0ml asm 31ga 6mm sm700177 sc) that went into finished batch# 7128822.Batch# 7128822, date(s) of manufacture: 18jun2017 thru 20jun2017, machine(s) manufactured on: (b)(4).Batch# 7114563, date(s) of manufacture: 08jun2017 thru 10jun 2017, machine(s) manufactured on: (b)(4), pils¿ there was one (1) batch of material# 700003981 (barrel 1.0ml shd 31ga 6mm sm700177).That went into finished batch# 7128822, batch# 7128822, date(s) of manufacture: 18jun2017 thru 20jun2017, machine(s) manufactured on: (b)(4).Batch# 7114563, date(s) of manufacture: 08jun2017 thru 10jun2107, machine(s) manufactured on: (b)(4).There was one (1) notification [(b)(4)] noted that did not pertain to the complaint.Bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect.

• Brand Name: 1ML, 31G X 6MM 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
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6967127
• MDR Text Key: 90755818
• Report Number: 1920898-2017-00258
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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
• Device Operator: Other
• Device Catalogue Number: 324912
• Device Lot Number: 7128822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other