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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB; PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB; PISTON SYRINGE Back to Search Results
Model Number 305950
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 4 cases of syringes alrg sftygld 1ml w/ndl 27x1/2 rb had difficult plunger movement.The following information was provided by the initial reporter: "the customer reported that four cases of bd pn 1cc 27g x ½ safety syringe (item# bd5950 lot# 0104234) had plungers that were difficult to move.".
 
Manufacturer Narrative
H.6.Investigation: the samples were received by bd for evaluation.A quality engineer was able to review the returned (3425) 1ml, 13mm, 27g bd safetyglide allergy syringes in 135 sealed trays from lot # 0104234 product # 305950 with the reported issue of ¿plungers were difficult to move¿.30 out of 3425 samples were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 0104234.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.
 
Event Description
It was reported that 4 cases of syringes alrg sftygld 1ml w/ndl 27x1/2 rb had difficult plunger movement.The following information was provided by the initial reporter: "the customer reported that four cases of bd pn 1cc 27g x ½ safety syringe (item# bd5950 lot# 0104234) had plungers that were difficult to move.".
 
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Brand Name
SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key11103419
MDR Text Key229408195
Report Number1920898-2020-01784
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903059509
UDI-Public30382903059509
Combination Product (y/n)N
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 01/07/2021
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 Other
Device Model Number305950
Device Catalogue Number305950
Device Lot Number0104234
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2020
Initial Date Manufacturer Received 12/04/2020
Initial Date FDA Received12/31/2020
Supplement Dates Manufacturer Received01/07/2021
Supplement Dates FDA Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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