MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306574

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1257152.Medical device expiration date: 31-aug-2024.Device manufacture date: 14-sep-2021.Medical device lot #: 1308768.Medical device expiration date: 31-oct-2024.Device manufacture date: 04-nov-2021.Medical device lot #: 1314069.Medical device expiration date: 31-oct-2024.Device manufacture date: 10-nov-2021.Initial reporter phone #: (b)(6).E.1 initial addr 1: 2 ploenchit center, 8-9 floor, sukhumvit road, kwaeng klongtoey, khet klongtoey h.3.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 the bd posiflush¿ pre-filled saline syringe experienced damaged unit packaging that compromised device sterility.The following information was provided by the initial reporter: the product envelope was torn.

Event Description

It was reported that the bd posiflush¿ pre-filled saline syringe experienced damaged unit packaging that compromised device sterility.The following information was provided by the initial reporter: the product envelope was torn.

Manufacturer Narrative

H6: investigation summary.A device history record review was completed for provided material number 306574 and lot number 1257152, 1308768, and 1314069.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, several unit packages were observed with torn film at the areas of the plunger and tip cap.This type of defect may result if the package length is cut too short due to the syringe being close to the cutting area.The tension applied on the packaging film at the tip cap and plunger rod areas could lead to film breakage.This type of defect may also result if the spikes that perforate the film of the unit package are not well adjusted.The perforation can then get too big and break the film packaging.If this type of damage occurs, the bigger holes may lead to torn film after the syringes are picked up and placed within the shelf cartons.A project has since been opened to further investigate this possible root-cause.The spike position will be adjusted to prevent this type of defect.The film packaging does not act as a sterile barrier and therefore, the fluid pathway has not been compromised.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.H3 other text : see h.10.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15183969
• MDR Text Key: 305089754
• Report Number: 3002682307-2022-00207
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

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 Catalogue Number: 306574
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1