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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE Back to Search Results
Model Number 309653
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: three (3) used samples were provided for investigation. As the samples had been used leak testing was not possible due to potential contamination. The three samples were visually examined using unaided vision and it was observed that all three (3) of the returned samples had dried foreign matter behind the stopper indicating that the liquid in the syringe had leaked past the stopper. Investigation conclusion: a device history record (dhr) review was performed on batch 9086543 associated with this investigation. The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued. A device history record (dhr) review was not able to be performed on the batches associated with this investigation as the lot number was unknown. Root cause description: leakage can be caused by the interaction between the barrel inside diameter, the stopper outside diameter, and plunger rod bayonet outside diameter and forces applied during use. The syringe is more likely to leak when forces are applied to the plunger rod when fully extended. Rationale: capa (b)(4) ¿ 60ml leakage past stopper has been completed. This capa involved going from 60ml to 50ml because it will increase the stability of the plunger rod. All bd product currently produced is of a 50ml volume. As batch 9086543 was produced prior to the capa completion and the other batch is not known, no additional corrective or preventative actions are proposed in the scope of this complaint. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 9086543, medical device expiration date: 2024-02-29, device manufacture date: 2019-03-27, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.
 
Event Description
It was reported that 3 syringe 60ml ll tip 1ml 2 oz in 1/4 oz experienced leakage past the stopper/plunger which was noted during use. The following information was provided by the initial reporter: material no. 309653 batch no. 9086543 and unknown per email: i have the issues reported below plus one additional syringe. Ref309653 lot9086543. We have complaints of plungers leaking on bd item 309653. Two items were saved but lot numbers were not recorded.
 
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Brand NameSYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9630011
MDR Text Key195221264
Report Number1911916-2020-00036
Device Sequence Number1
Product Code FMF
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
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309653
Device Catalogue Number309653
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2020 Patient Sequence Number: 1
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