MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL WWD; PISTON SYRINGE

Model Number	301997
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 10ml ll wwd was damaged, but still operable and the plunger rod was broken.The following information was provided by the initial reporter: "this is a report about a damaged syringe.When aspirating saline using this syringe, the hcp found that the barrel and plunger rod were damaged/deformed.The affected product was thus not used.The customer is asking bd to return the affected product to japan after the completion of investigation.".
Additional Manufacturer Narrative
H6: investigation summary four photos and one loose 10ml syringe were received and evaluated.It was observed there was significant indentations between the 2 and 5ml markings and above the 10ml marking.The plunger rod was damaged in consistent locations.The damage was rejectable per product specification.Potential root cause for the damaged barrel defect is associated with the assembly process.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.
Event or Problem Description
It was reported that syringe 10ml ll wwd was damaged, but still operable and the plunger rod was broken.The following information was provided by the initial reporter: "this is a report about a damaged syringe.When aspirating saline using this syringe, the hcp found that the barrel and plunger rod were damaged/deformed.The affected product was thus not used.The customer is asking bd to return the affected product to japan after the completion of investigation.".

• Brand Name: SYRINGE 10ML LL WWD
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10759560
• Report Number: 1213809-2020-00765
• Device Sequence Number: 11638001
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/04/2020

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 Model Number: 301997
• Device Catalogue Number: 301997
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1