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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE Back to Search Results
Model Number 328291
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. The customer's address is unknown. (b)(6) usa has been used as a default. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot. Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported that a syringe 0. 3ml 8mm 90 bx 450 mo had a broken thumb press. The following was reported by the initial reporter: "it was reported that the needle came off with the cap and one syringe was missing the end of the plunger. Verbatim: email received¿2021-04-05 10:21:32i received a box of one hundred 3/10 cc\\ml, 8 mm, 31 gauge insulin syringes containing several defective syringes. Several syringes had needle caps that when i removed them by pulling the needle cap straight off, the needle came off in the cap and could not be removed. (i did not twist or bend the needle cap when removing it)there was also one syringe missing the end of the plunger. I have used bd insulin syringes for over 40 years and have never had defective syringes like theselot # 0090638 bmanufacture date 5/1/20expiration date 4/30/25".
 
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Brand NameSYRINGE 0.3ML 8MM 90 BX 450 MO
Type of DevicePISTON 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11758799
MDR Text Key249512679
Report Number1920898-2021-00503
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328291
Device Catalogue Number328291
Device Lot Number0090638
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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