• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE Back to Search Results
Catalog Number 309605
Device Problems Crack (1135); Dent in Material (2526)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1081409, medical device expiration date: 2026-02-28, device manufacture date: (b)(6) 2021. Medical device lot #: 1081410, medical device expiration date: 2026-02-28, device manufacture date: (b)(6) 2021. Investigation summary: seven photos and thirty-five 10ml syringes (material 309605) were received. The samples were visually evaluated. The samples were separated by batch with thirteen from batch 1081410 and twenty-two from batch 1081409. Six samples from batch 1081410 and seven samples from batch 1081409 were observed to have damage on the barrel that was non-conforming per product specification. It was found during the investigation that one of the sub-assembly batches had a quality notification generated for potential damaged components resulting from a disconnected airline at the assembly reject station. The product was requalified per procedure at the assembly and at the packaging machine during production of batch 1081410. The affected sub-assembly batch was used in the manufacture of the two packaging batches received by the customer. Additionally, the two packaging batches were run consecutively. Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the batch number 1081409 that could have contributed to the reported defect. Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: potential root cause for the incorrect assembly defect is associated with the assembly process. The disconnected airline at the assembly reject station likely contributed to damaged parts getting through. The defect was detected prior to batch 1081410 leaving the facility and product requalified per applicable acceptable quality limit. It is possible that not all defects were contained as part of the requalification activities and a limited number with this condition were not detected. Rationale: these conditions are occurring at/below their expected frequency. Therefore, no corrective action is required at this time. Batches 1081409 and 1081410 are considered in compliance with our product specification requirements.
 
Event Description
It was reported that syringe 10ml ll tip bulk convenience pak was cracked. This occurred on 80 occasions. The following information was provided by the initial reporter: it was reported that during a quality check the syringes were noticed to be cracked with dents on them.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGE 10ML LL TIP BULK CONVENIENCE PAK
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12163551
MDR Text Key266690226
Report Number1213809-2021-00492
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 distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309605
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2021
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

-
-