MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 1/2IN; PISTON SYRINGE

Catalog Number 328279

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 1 bd syringe 0.5ml 1/2in cannula broke off.The following information was provided by the initial reporter: the consumer reported that a syringe is taken out and filled up to max to use multi times throughout the day.The new insulin manufactured humalog vials have a harder rubber than novo and bends the needle resulting in one needle slipping out of the syringe and stayed in the vial when drawing up insulin.Date of event: unknown.Samples: available.

Event Description

It was reported that 1 bd syringe 0.5ml 1/2in cannula broke off.The following information was provided by the initial reporter : the consumer reported that a syringe is taken out and filled up to max to use multi times throughout the day.The new insulin manufactured humalog vials have a harder rubber than novo and bends the needle resulting in one needle slipping out of the syringe and stayed in the vial when drawing up insulin.Date of event : unknown.Samples : available.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 1353029.D4: medical device expiration date: na h4: device manufacture date: 2012-02-10.D4: medical device lot #: unknown.D4: medical device expiration date: unknown.H4: device manufacture date: unknown.D10: device available for eval yes.D10: returned to manufacturer on: 2021-10-14.Investigation summary customer returned a polybag with 7 syringes labeled for 0.5ml, 30 gauge, 12.7mm syringes from lot 1353029, an empty insulin vial, and a loose syringe.The loose syringe was observed to have separate marking from the other syringes returned in the polybag, and its needle shield was a lighter color.It is believed to be separate from the returned polybag and could not be properly identified.The syringes were all inspected.The only syringe with any damage of any kind was found to be the syringe with the separate markings and lighter needle shield, which featured a bent needle.The bend occurred at the base of the needle and was not significant enough to impede replacing the needle shield.It appears to have been bent during use.The returned insulin vial was inspected.No needles were found inside the vial.None of the syringes returned were missing needles.Due to the batch being manufactured in 2012 and files are retained for 7 years, no dhr review can be completed.Based on the samples received, bd was unable to confirm the customer¿s indicated failure of a needle cannula separating.

• Brand Name: BD SYRINGE 0.5ML 1/2IN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12542691
• MDR Text Key: 273665057
• Report Number: 1920898-2021-01020
• Device Sequence Number: 1
• Product Code: FMF
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328279
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1