MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 5ML SALINE 5ML FILL; SALINE FLUSH

Model Number	306545
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was reported that the bd syringe 5ml saline flush had a deformed plunger found before use.Verbatim: ¿complaint from reporting facility.The user complained that the plunger was deformed.
Event or Problem Description
It was reported that the bd syringe 5ml saline flush had a deformed plunger found before use.Verbatim: ¿complaint from reporting facility.The user complained that the plunger was deformed.
Additional Manufacturer Narrative
H.6.Investigation: two photos were provided for evaluation.They show the plunger rod thumb press damaged.After the labeling of the syringe, the flow wrap packaging process is performed.When a syringe is not positioned in the right location, the mechanism doing the sealing of the flow wrap hits the plunger rod thumb press creating the damage shown in the photos.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.H3 other text : see h.10.

• Brand Name: BD SYRINGE 5ML SALINE 5ML FILL
• Common Device Name: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9688232
• Report Number: 1911916-2020-00114
• Device Sequence Number: 2891152
• Product Code: NGT
• UDI-Device Identifier: 30382903065456
• UDI-Public: 30382903065456
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: Other
• Device Expiration Date: 01/31/2022
• Device Model Number: 306545
• Device Catalogue Number: 306545
• Device Lot Number: 9051627
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 02/21/2020
• 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