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

Catalog Number 304086

Device Problems Crack (1135); Entrapment of Device (1212); Short Fill (1575); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8025585.Medical device expiration date: n/a.Device manufacture date: 2018-01-25.Medical device lot #: 8057936.Medical device expiration date: n/a.Device manufacture date: 2018-02-26.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 no water inside syringe occurring in 2 batch numbers that were received.Initial email rcvd from bard malaysia: "please be informed that we have received multiple customer complaints regarding short fill (to date 15 complaints have been launched).Upon evaluation of 4 samples returned, foreign matter (plastic debris) from the plunger was found stuck or trapped in between the plunger tip and inner wall of the barrel.It is believed that this has caused void or channel from where water leak post manufacturing.Additional information: same failure modes detected for all 4 samples which we have received.Plastic debris material matches material of plunger (confirmed through ftir test).No crack observed on returned samples.All the complaints occurred before use (pre-test).

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The reported issue was previously investigated under another complaint: scar was also completed: 2 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 od and the barrel id, 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.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.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.Corrective and preventive action: 1.A quality alert was sent on 12/07 to all canaan's personnel for awareness of the foreign matter found in (b)(4) 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.Situational analysis mds-19-1448-sa opened to evaluate the foreign matter issue associated with all complaints received so far and capa: 768379 was also initiated.

Event Description

It was reported that bd¿ syringe 10cc s/t wos sterile water bns had no water inside syringe occurring in 2 batch numbers that were received.Initial email rcvd from bard malaysia: "please be informed that we have received multiple customer complaints regarding short fill (to date 15 complaints have been launched).Upon evaluation of 4 samples returned, foreign matter (plastic debris) from the plunger was found stuck or trapped in between the plunger tip and inner wall of the barrel.It is believed that this has caused void or channel from where water leak post manufacturing.Additional information: 1.Same failure modes detected for all 4 samples which we have received.2.Plastic debris material matches material of plunger (confirmed through ftir test) 3.No crack observed on returned samples.4.All the complaints occurred before use (pre-test).

• 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: 8375647
• MDR Text Key: 137937905
• Report Number: 1213809-2019-00290
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 304086
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other