MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 5ML LL W/NDL SFTYGLD 22X1-1/2 RB

Model Number	305907
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Pma/510(k)#: an additional pma/510(k)# is listed for this device as k951254.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the syringe 5ml ll w/ndl sftygld 22x1-1/2 rb experienced a misaligned/jammed/insecure stopper and stopper damage/deformation.Product defects were noted prior to use.The following information was provided by the initial reporter: congestion deformation.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for evaluation? yes.D.10 returned to manufacturer on: (b)(6) 2020.H.6.Investigation summary as a lot number was unknown for this incident, a review of the production history could not be completed for this specific product.To aid in the investigation of this issue, one physical sample was returned for evaluation by our quality engineer team.Through examination of the opened sample, the stopper was found to be distorted within the syringe.Based on the investigation results, an exact manufacturing related cause could not be determined for this incident.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.
Event or Problem Description
It was reported that the syringe 5ml ll w/ndl sftygld 22x1-1/2 rb experienced a misaligned/jammed/insecure stopper and stopper damage/deformation.Product defects were noted prior to use.The following information was provided by the initial reporter: congestion deformation.

• Brand Name: SYRINGE 5ML LL W/NDL SFTYGLD 22X1-1/2 RB
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10222540
• Report Number: 9610847-2020-00197
• Device Sequence Number: 14163500
• Product Code: FMF
• UDI-Device Identifier: 30382903059073
• UDI-Public: 30382903059073
• 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): 08/24/2020

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: 305907
• Device Catalogue Number: 305907
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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