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

Model Number	301997
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that syringe 10ml ll wwd plunger rod was damaged.This was discovered before use.The following information was provided by the initial reporter: during mfg process at togo medikit, fm attached product was confirmed.
Event or Problem Description
It was reported that syringe 10ml ll wwd plunger rod was damaged.This was discovered before use.The following information was provided by the initial reporter: during mfg process at togo medikit, fm attached product was confirmed.
Additional Manufacturer Narrative
H.6.Investigation: three photos and one loose 10ml syringe was received and evaluated.It was observed there was a single embedded foreign matter particle on one of the ribs of the plunger rod approximately 0.75¿ below the thumb rest.The particle appeared to be burnt plastic and was larger than level 3 in size which was rejectable per product specification.The plunger rod was from mold m-79 cavity 28.A potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded fm is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Unfortunately, batch/lot information is required to make corrective action determinations.No corrective actions are necessary at this time.H3 other text : see h.10.

• 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: 10111743
• Report Number: 1213809-2020-00356
• Device Sequence Number: 2405526
• 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): 06/23/2020

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: 05/29/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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