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

Catalog Number 328438

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462); Foreign Body In Patient (2687)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows : lot # : 3008246 ¿ device expiration date : unknown; ¿ device manufacture date : 03/06/2013.Lot # : unknown ¿ device expiration date : unknown; ¿ device manufacture date : unknown.Investigation summary : exec summary - no samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.Unable to perform complaint lot history check owing to an unknown lot number for this event.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - no dhr review can be carried out as the lot number is unknown for this event.

Event Description

It was reported that 1 bd insulin syringes with the bd ultra fine¿needle cannula broke off.The following information was provided by the initial reporter : the consumer reported a needle that fell to the floor where the consumer stepped on the needle that could not be remove from the foot and bleeding occurred.Consumer went to er where a numbing solution was used on the site to remove needle from foot, no xray was completed or surgery.Date of event : unknown.Sample status : discarded.

• Brand Name: BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12709285
• MDR Text Key: 278769523
• Report Number: 1920898-2021-01114
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2021

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: 328438
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2013
• 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