MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 26 G X 3/8 IN.; CONVENTIONAL SYRINGE

Catalog Number	305539
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 1 ml bd¿ allergy syringe with permanently attached needle 26 g x 3/8 in.Contained foreign matter.No serious injury or medical intervention reported.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex:; event attributed to:; device single use?:; device returned to manufacture:.
Event or Problem Description
It was reported that 1 ml bd¿ allergy syringe with permanently attached needle 26 g x 3/8 in.Contained foreign matter.No serious injury or medical intervention reported.
Event or Problem Description
It was reported that 1 ml bd¿ allergy syringe with permanently attached needle 26 g x 3/8 in.Contained foreign matter.No serious injury or medical intervention reported.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A dhr check was not performed as the lot number is "unknown" for this complaint.Severity: s_1__; occurrence: a complaint history check was not performed as the lot number is "unknown" for this complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: 1 ML BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 26 G X 3/8 IN.
• Common Device Name: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7736376
• Report Number: 1920898-2018-00562
• Device Sequence Number: 1618569
• Product Code: FMF
• UDI-Device Identifier: 00382903055395
• UDI-Public: 00382903055395
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2018

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: 305539
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 07/12/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 09/05/2018; 09/24/2018
• 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