MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML; PISTON SYRINGE

Model Number	305536
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use of a bd¿ allergy syringe with permanently attached needle 27 g x 3/8 in., 0.5 ml, the needle penetrated through the shield.The patient required a bandage for a puncture wound and scratch.The following information was provided by the initial reporter: a registered nurse reported that she received a needle stick from a bent needle that came through the side of the syringe.
Additional Manufacturer Narrative
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 prior to use of a bd¿ allergy syringe with permanently attached needle 27 g x 3/8 in., 0.5 ml, the needle penetrated through the shield.The patient required a bandage for a puncture wound and scratch.The following information was provided by the initial reporter: a registered nurse reported that she received a needle stick from a bent needle that came through the side of the syringe.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-mar-2022 h6: investigation summary the samples were received by bd for evaluation.A quality engineer was able to review the returned samples of (2) loose 1/2ml syringes without any packaging from lot # 1077585 product # 305536 with the reported issue of ¿needle bent¿.Both returned syringes were examined and both exhibited a bent cannula.A review of the device history record was completed for batch #1077585.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples and/or photo(s) received the investigation concluded that bd was able to duplicate or confirm the indicated failure.Root cause cannot be determined at this time as the samples were returned loose and may have been used.H3 other text : see h10.

• Brand Name: BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML
• Common Device Name: 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: 13668010
• Report Number: 1920898-2022-00144
• Device Sequence Number: 4756370
• Product Code: FMF
• UDI-Device Identifier: 30382903055365
• UDI-Public: 30382903055365
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 305536
• Device Catalogue Number: 305536
• Device Lot Number: 1077585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female