MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SYRINGE 10CC S/T WOS STERILE WATER BNS

Catalog Number 304086

Device Problems Volume Accuracy Problem (1675); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

Event Type  malfunction  

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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd¿ syringe 10cc s/t wos sterile water bns had foreign matter, inaccuracy filled volume, and leakage before use.

Manufacturer Narrative

Correction: date of event: (b)(6) 2018.Date received by manufacturer: 11/29/2018.

Event Description

It was reported that bd¿ syringe 10cc s/t wos sterile water bns had foreign matter, inaccuracy filled volume, and leakage before use.

Manufacturer Narrative

Investigation summary: two samples received have a small clear foreign matter (fm) of approx.0.26¿ and 0.35¿ long, the fm is a plastic piece trapped between the stopper outside dimension and the barrel inside dimension.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number(s) that could have contributed to the reported defect.Investigation conclusion: the plastic piece was identified to be from the outside of the barrel flange.Both barrels present a small damage that caused the loose foreign matter - most likely the loose fm somehow was assembled along with the other components during processing.No additional test performed on the two samples received, only visual inspection.Root cause description: after exhaustive review of the assembly process, it was concluded that the damage found in the barrel was caused due to improper setup of the silicone gun used to spray medical grade silicone inside the barrel.If the silicone gun is setup loose, it could contact and damage the barrel during processing.Rationale: a situational analysis was opened to evaluate the foreign matter issue associated with all complaints received so far and capa: 768379 was also initiated.Corrective and preventive action includes; 1.A quality alert was sent on 12/07 to all canaan's personnel for awareness of the foreign matter found in p/n 304086 by customers in japan.2.Set up pins were put in place on 12/21 to prevent the silicone guns from being improperly setup or moved to a position where they could damage barrels.3.A preventive maintenance task was added on 12/21 in order to verify and ensure that the guns are set up correctly and that the pins are in place.

Event Description

It was reported that bd¿ syringe 10cc s/t wos sterile water bns had foreign matter, inaccuracy filled volume, and leakage before use.

Manufacturer Narrative

Correction: in the previously submitted mdr, brand name and type of reportable event were incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: medical device expiration date, device manufacture date.

Event Description

It was reported that bd¿ syringe 10cc s/t wos sterile water bns had foreign matter, inaccuracy filled volume, and leakage before use.

• Brand Name: BD¿ SYRINGE 10CC S/T WOS STERILE WATER BNS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8190824
• MDR Text Key: 131319234
• Report Number: 1213809-2018-00920
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 304086
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other