MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW; PISTON SYRINGE

Model Number	305274
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7177705.Medical device expiration date: 2022-06-30.Device manufacture date: 2017-06-26.Medical device lot #: 8317519.Medical device expiration date: 2023-10-31.Device manufacture date: 2018-11-13.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that the bd¿ syringe integra 3ml w/ndl 21x1-1/2 rb tw has been found experiencing two occurrences of needle retraction failure during use.The following has been provided by the initial reporter: it was reported that the needles are not retracting.Per phone call on 03-dec-2019: reporter stated that their nurses have been reporting that the needles are not retracting.They have maybe a 10-20% success rate with these boxes.9 vaccinations today and only 2 worked.Also on other occasions.Unused samples are available.
Event or Problem Description
It has been reported that the bd¿ syringe integra 3ml w/ndl 21x1-1/2 rb tw has been found experiencing two occurrences of needle retraction failure during use.The following has been provided by the initial reporter: it was reported that the needles are not retracting.Per phone call on 03-dec-2019: reporter stated that their nurses have been reporting that the needles are not retracting.They have maybe a 10-20% success rate with these boxes.9 vaccinations today and only 2 worked.Also on other occasions.Unused samples are available.
Additional Manufacturer Narrative
Ten 3ml integra syringes with needle in fully sealed blister packs (p/n 305274) were received and evaluated.Five were from batch 7177705 and five were from batch 8317519.All the syringes were disassembled, and each component was visually inspected.The syringes were then reassembled, and the retraction mechanism was activated with all the needles retracting as expected.No visual or functional defects were observed.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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.H3 other text : see section h.10.

• Brand Name: BD SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9491221
• Report Number: 1213809-2019-01275
• Device Sequence Number: 13922549
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other