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U.S. Department of Health and Human Services

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
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BD MEDICAL - DIABETES CARE BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML; PISTON SYRINGE Back to Search Results
Model Number 305536
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/21/2022
Event Type  malfunction  
Event 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.
 
Manufacturer Narrative
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 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.
 
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.
 
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Brand Name
BD¿ ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE 27 G X 3/8 IN., 0.5 ML
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13668010
MDR Text Key286928787
Report Number1920898-2022-00144
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903055365
UDI-Public30382903055365
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Model Number305536
Device Catalogue Number305536
Device Lot Number1077585
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2022
Initial Date FDA Received03/04/2022
Supplement Dates Manufacturer Received03/24/2022
Supplement Dates FDA Received04/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age48 YR
Patient SexFemale
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