MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE FILL SPKG; INTRAVASCULAR CATHETER

Model Number 306553

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2020

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 34 syringe 10ml reg pr saline fill spkg experienced damaged, or open unit packaging/seals where sterility was compromised.Product defects were noted prior to use.The following information was provided by the initial reporter: nonconformance description: trim in seal / defective packaging.Trim and brown substance found on 34 each of component 306553, lot 0090278.

Event Description

It was reported that 34 syringe 10ml reg pr saline fill spkg experienced damaged or open unit packaging/seals where sterility was compromised.Product defects were noted prior to use.The following information was provided by the initial reporter: nonconformance description: trim in seal / defective packaging.Trim and brown substance found on 34 each of component 306553, lot 0090278.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 2020-08-21.H.6.Investigation summary: a device history record review was performed for provided lot number 0090278 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture samples and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, foreign material was observed on the packaging of the syringes.It has been determined that this incident resulted from an error in the waste trim removal pipe within the packaging machinery.An adjustment to the waste trim removal pipe has been made to ensure proper function and to prevent this issue from recurring.H3 other text : see h.10.

• Brand Name: SYRINGE 10ML REG PR SALINE FILL SPKG
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10488272
• MDR Text Key: 206875856
• Report Number: 9616657-2020-00136
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: 0090278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other