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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SEE H10; SALINE FLUSH SYRINGE
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BECTON, DICKINSON AND CO. SEE H10; SALINE FLUSH SYRINGE Back to Search Results
Catalog Number 306572
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The original complaint information date received by manufacturer has been used for this field.Medical device brand name: bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.Initial reporter phone #: (b)(6).Initial reporter fax #: (b)(6).(b)(4).Investigation summary: a device history record review was performed for provided lot number 0223146 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, five physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, damage to the product packaging was observed.It is possible that this incident resulted from jams in the multivac machinery, which caused contamination in the trim catching chain.This issue has been identified and resolved by the manufacturing team to prevent further defects.Our quality team will continue to monitor the production process for this potential defect and any emerging trends.Investigation conclusion: based on the investigation, it is possible the package damage may be related to trim jams on the multivac which may have caused contamination from the trim catching the chain.The issue was identified and resolved at the time of occurrence.
 
Event Description
It was reported that 61 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced damaged or open unit packaging/seal where sterility was compromised.The following information was provided by the initial reporter: we have recently received repeated messages from our packaging department that the packages of bd posiflush art.No.306572 are torn, damaged and partially dirty (inside).At the moment we have 61 pieces, batch 0223146 from our packaging received back.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/16/2020.H.6.Investigation: a device history record review was performed for provided lot number 0223146 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, five physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, foreign matter and damage to the product packaging was observed.It is possible that this incident resulted from jams in the multivac machinery, which caused contamination in the trim catching chain.
 
Event Description
It was reported that 61 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced damaged or open unit packaging/seal where sterility was compromised.The following information was provided by the initial reporter: we have recently received repeated messages from our packaging department that the packages of bd posiflush art.No.306572 are torn, damaged and partially dirty (inside).At the moment we have 61 pieces, batch 0223146 from our packaging received back.
 
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Brand Name
SEE H10
Type of Device
SALINE FLUSH SYRINGE
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key11208426
MDR Text Key228434741
Report Number9616657-2021-00010
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/25/2021
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 Expiration Date07/31/2023
Device Catalogue Number306572
Device Lot Number0223146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Initial Date Manufacturer Received 12/23/2020
Initial Date FDA Received01/21/2021
Supplement Dates Manufacturer Received01/25/2021
Supplement Dates FDA Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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