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 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was performed for provided lot number 9060999 and the review did not reveal any detected abnormalities during the production process that could have contributed to this incident.To further investigation this issue, physical samples were provided for evaluation by our quality team.Through examination of the samples, package damage was observed.It has been determined that the package damage may be a result of a misalignment of the syringe within the blister packaging, causing further issues in the packaging and sterilization process.This incident is being further investigated with engineering leadership to detect the exact cause and prevent this issues recurrence.Investigation conclusion: batch code: 9060999.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.The samples returned confirmed package damaged.Root cause description: the issue has been investigated with plant engineering leadership, and the root cause may be related to the alignment of the syringe flange in the blister packs following the robot transfer from the syringe loader to the steriliser trays prior to sterilisation.Additional root causes are being explored, including post sterilisation handling conditions.

Event Description

It was reported that 10 syringes 10ml reg pr saline fill spkg experienced damaged or open unit packaging/seal where sterility was compromised.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 306553 , batch no.: 9060999.On (b)(6) 2020 during incoming inspection qa found 10 syringe packets with holes.

Event Description

It was reported that 10 syringes 10ml reg pr saline fill spkg experienced damaged or open unit packaging/seal where sterility was compromised.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 306553, batch no.: 9060999.On 1/17/2020 during incoming inspection qa found 10 syringe packets with holes.

Manufacturer Narrative

Bd is conducting a voluntary medical device recall (mds-20-1971-fa) for multiple lots of the bd posiflush¿ sf (sterile field) saline flush syringe 10ml and the bd posiflush¿ xs (externally sterile) 10 ml syringe.This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.While the sterility of the outer surface of the syringe may be compromised, the saline solution and the sterile path of the syringe are not impacted.The root cause investigation is ongoing and will be documented in capa # 1472554; however, the issue has been isolated to product manufactured using one single packaging line.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9060999 and the review did not reveal any detected abnormalities during the production process that could have contributed to this incident.To further investigation this issue, physical samples were provided for evaluation by our quality team.Through examination of the samples, package damage was observed.It has been determined that the package damage may be related to the alignment of the syringe flange in the blister packs following the robot transfer from the syringe loader to the steriliser trays prior to sterilisation.

Event Description

It was reported that 10 syringes 10ml reg pr saline fill spkg experienced damaged or open unit packaging/seal where sterility was compromised.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 306553.Batch no.: 9060999.On 1/17/2020 during incoming inspection qa found 10 syringe packets with holes.

• 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: 9901445
• MDR Text Key: 203103340
• Report Number: 9616657-2020-00050
• 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: other,user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: 9060999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MDS-20-1971-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Other