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

Catalog Number 328468

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/15/2022

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.Medical device manufacture date: unknown.

Event Description

It was reported that 1 bd insulin syringe with the bd ultra fine¿needle cannula broke off.The following information was provided by the initial reporter: the consumer reported needle broke off in left-side stomach during use and removed by the consumer, did not seek medical attention.Date of event: unknown.Samples: available.

Manufacturer Narrative

Investigation summary: customer returned (2) 0.5ml bd insulin syringes from lot# 1200429.The customer reported 2 syringes with a missing needle prior to use, and a needle broke during use.The samples were examined, and it was observed that 1 syringe featured a needle hub/shield assembly detached from the barrel; no damage to the barrel tip was observed on the sample.The other syringe featured a broken cannula.Microscopic examination of this syringe revealed characteristics such as residual bends on the hub-end of the fractured cannula, and ovality (deformation from the normally circular cross section) ¿ removal of the epoxy made this evident.When viewed together these are all indicators of bending/re-straightening mode of failure.A review of the device history record was completed for batch# 1200429.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (cannula broken).Bd was able to duplicate or confirm the customer¿s indicated failure (hub separates).The root cause for this issue is user related.The cannula was broken by the user after handling the syringe.Capa pr1630423 has been opened to address (hub separates).H3 other text : see h10.

Event Description

It was reported that 1 bd insulin syringe with the bd ultra fine¿needle cannula broke off.The following information was provided by the initial reporter : the consumer reported needle broke off in left-side stomach during use and removed by the consumer, did not seek medical attention.Date of event : unknown.Samples : available.

• Brand Name: BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE
• Type of Device: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13982347
• MDR Text Key: 288798200
• Report Number: 1920898-2022-00211
• 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: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328468
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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