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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ SF SALINE SYRINGE; INTRAVASCULAR CATHETER
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BECTON, DICKINSON AND CO. BD POSIFLUSH¿ SF SALINE SYRINGE; INTRAVASCULAR CATHETER Back to Search Results
Model Number 306553
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 sterile breach occurred with a bd posiflush¿ sf saline syringe.The following information was provided by the initial reporter, "it was reported that syringes are being found with cuts in pouches."saline syringe units (1 per pack) are being found in tandem packaging with cuts in the pouches." is the date of event known? around (b)(6) 2019.How many syringes were found with the reported issue? 200 +.For clarification, in addition to the issue with syringes being found with cuts in pouches were there any additional issues to report? no.".
 
Manufacturer Narrative
The following are the changes: b.5.Describe event or problem: it was reported that sterile breach occurred with a bd posiflush¿ sf saline syringe.The following information was provided by the initial reporter, "it was reported that syringes are being found with cuts in pouches."saline syringe units (1 per pack) are being found in tandem packaging with cuts in the pouches." the events occurred before use.791 occurrences with lot 9011582.335 occurrences with lot 9017875.30 occurrences with lot 9024676.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 9011582.D.4.Medical device expiration date: 2021-12-31.H.4.Device manufacture date: 2019-01-11.D.4.Medical device lot #: 9017875.D.4.Medical device expiration date: 2021-12-31.H.4.Device manufacture date: 2019-01-17.D.4.Medical device lot #: 9024676.D.4.Medical device expiration date: 2022-01-31.H.4.Device manufacture date: 2019-01-24 h3 other text : see.H.10.
 
Event Description
It was reported that sterile breach occurred with a bd posiflush¿ sf saline syringe.The following information was provided by the initial reporter, "it was reported that syringes are being found with cuts in pouches."saline syringe units (1 per pack) are being found in tandem packaging with cuts in the pouches." the events occurred before use.791 occurrences with lot 9011582.335 occurrences with lot 9017875.30 occurrences with lot 9024676.
 
Manufacturer Narrative
H.6.Investigation: bd was able to verify the reported complaint of packaged damaged on the returned samples of lot 9011582.The non-conformances were reviewed for this batch, and there was one non-conformance associated with this batch that could have contributed to the identified issue.It is possible that there may have been a technical issue with the infeed rollover pads during production.The other two lots were verified based on similar issue reported despite were no non-conformances associated with this batch that could have contributed to the identified issue and having a returned sample for the lots.H3 other text : see h.10.
 
Event Description
It was reported that sterile breach occurred with a bd posiflush¿ sf saline syringe.The following information was provided by the initial reporter, "it was reported that syringes are being found with cuts in pouches."saline syringe units (1 per pack) are being found in tandem packaging with cuts in the pouches." is the date of event known? around (b)(6) 2019.How many syringes were found with the reported issue? 200 + for clarification, in addition to the issue with syringes being found with cuts in pouches were there any additional issues to report? no".
 
Manufacturer Narrative
The new information is as follows: 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.
 
Event Description
It was reported that sterile breach occurred with a bd posiflush¿ sf saline syringe.The following information was provided by the initial reporter, "it was reported that syringes are being found with cuts in pouches."saline syringe units (1 per pack) are being found in tandem packaging with cuts in the pouches." the events occurred before use.791 occurrences with lot 9011582.335 occurrences with lot 9017875.30 occurrences with lot 9024676.
 
Manufacturer Narrative
The new information is as follows: 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.H3 other text : see h.10.
 
Event Description
It was reported that sterile breach occurred with a bd posiflush¿ sf saline syringe.The following information was provided by the initial reporter, "it was reported that syringes are being found with cuts in pouches."saline syringe units (1 per pack) are being found in tandem packaging with cuts in the pouches." the events occurred before use.791 occurrences with lot 9011582.335 occurrences with lot 9017875.30 occurrences with lot 9024676.
 
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Brand Name
BD POSIFLUSH¿ SF SALINE SYRINGE
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key8678732
MDR Text Key156955325
Report Number9616657-2019-00228
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065531
UDI-Public30382903065531
Combination Product (y/n)N
PMA/PMN Number
K153481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2021
Device Model Number306553
Device Catalogue Number306553
Device Lot NumberSEE H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2019
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberMDS-20-1971-FA
Patient Sequence Number1
Patient Outcome(s) Other;
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