MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE BLS 500CAS CA

Catalog Number	329461
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle of bd¿ syringe bls 500cas ca were bent, and the medication could not be pushed out.Customer¿s verbatim: ¿ the tips of the needles are bent and the medication cannot be pushed out.Some in the box are fine and others are not.They are having to open a pack, see if it is bent and then they have been throwing them away if they are.So far they have only opened 2 boxes of the 5 they ordered".
Additional Manufacturer Narrative
The customer confirmed that the device was a medline product and not a bd device.Therefore, the information was revaluated, and does not meet our reporting criteria.
Event or Problem Description
It was reported that the needle of bd¿ syringe bls 500cas ca were bent, and the medication could not be pushed out.Customer¿s verbatim: the tips of the needles are bent and the medication cannot be pushed out.Some in the box are fine and others are not.They are having to open a pack, see if it is bent and then they have been throwing them away if they are.So far they have only opened 2 boxes of the 5 they ordered.

• Brand Name: BD SYRINGE BLS 500CAS CA
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8466392
• Report Number: 1920898-2019-00296
• Device Sequence Number: 16457143
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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
• Operator of Device: Other
• Device Catalogue Number: 329461
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other