MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB; PISTON SYRINGE

Model Number	305905
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 23x1 rb was deformed.The following information was provided by the initial reporter: distorted and the other is deformed.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 23x1 rb was deformed.The following information was provided by the initial reporter: distorted and the other is deformed.
Additional Manufacturer Narrative
H.6.Investigation: one opened blister package, confirmed to be from batch #9360282 (p/n 305905), and two loose 3ml syringes with safetyglide needles attached were received.The samples were visually evaluated.One syringe was observed to have a severely bent cannula in multiple spots underneath the shield.One syringe was observed to have a broken off thumb rest from the plunger rod.Potential root cause for broken plunger rod defect is associated with the assembly process.It is possible that the needle was not properly centered when the plastic shield was to be assembled inducing the needle to bend.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.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.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10837766
• Report Number: 1213809-2020-00796
• Device Sequence Number: 19637414
• Product Code: FMF
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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
• Operator of Device: Other
• Device Expiration Date: 11/30/2024
• Device Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: 9360282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1