MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 1ML CLEAR STERILE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number 305851

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 3 syringes oral 1ml clear sterile had damaged stoppers found before use.The following information was provided by the initial reporter: "syringes were damaged around the plunger.".

Manufacturer Narrative

H.6.Investigation summary: one photo and one loose 1ml syringe were received and evaluated.It was observed in the photo and physical sample, the stopper was not attached to the plunger rod, which was rejectable per product specification.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.The potential root cause for the insecure stopper defect is associated with the assembly process.Dhr review: release date: 1/13/2020.Released quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 9353359 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.H3 other text : see h.10.

Event Description

It was reported that 3 syringes oral 1ml clear sterile had damaged stoppers found before use.The following information was provided by the initial reporter: "syringes were damaged around the plunger.".

• Brand Name: SYRINGE ORAL 1ML CLEAR STERILE
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10610994
• MDR Text Key: 214833493
• Report Number: 1213809-2020-00680
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 30382903058519
• UDI-Public: 30382903058519
• Combination Product (y/n): N
• PMA/PMN Number: K112434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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
• Device Operator: Other
• Device Model Number: 305851
• Device Catalogue Number: 305851
• Device Lot Number: 9353359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other