MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problems Leak/Splash (1354); Component Missing (2306); Dent in Material (2526); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Initial reporter: address unavailable.Bd corporate address used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Material no: 306546 batch no: 8232966.It was reported that during use of the syringe 10ml reg pr saline 10ml fill saline was "squirting out the plunger end" when he was trying to flush.It was also reported that some packages were empty, and some flushes had dents in the sides.Pt voiced concern that she has had problems with picc line in past and is concerned about flushes not being sterile.She requested (b)(6) test the defective syringes in the event she has to go to the hospital so she can tell them what to treat for.Pharmacy manager, spoke with pt and said we would contact physician to draw blood cultures.Physician office has been contacted.The following information was provided by the initial reporter: pt caregiver called to say that saline was "squirting out the plunger end" when he was trying to flush.They also reported that there were some flushes "still in wrappers" that were empty and others had "dents" in the sides, but were not leaking.The caregiver reported the box is not damaged.Arranged for replacement flushes to be sent and to return all of the flushes in that box and the defective ones so we could inspect them and make a report.Received returned flushes and upon inspection - there were no flushes that were empty in the wrappers, but there were some that were still wrapped and had "dents" in the side of the syringe.A few "used" syringes - also had "dents" in approximately the same spot.No syringes were leaking, even when pressure was applied to the plunger.The caregiver sent back the affected lot # as well as others they had in the house.Called pt caregiver to clarify report of empty syringes in wrappers, and the caregiver said they did throw a few away.Asked about pets in the house, and they do have them but say they do not get into the supplies.Pt voiced concern that she has had problems with picc line in past and is concerned about flushes not being sterile.She requested (b)(6) test the defective syringes in the event she has to go to the hospital so she can tell them what to treat for.Pharmacy manager, spoke with pt and said we would contact physician to draw blood cultures.Physician office has been contacted, but we had to leave message with answering service.

Event Description

Material no: 306546 batch no: 8232966 it was reported that during use of the syringe 10ml reg pr saline 10ml fill saline was "squirting out the plunger end" when he was trying to flush.It was also reported that some packages were empty, and some flushes had dents in the sides.Pt voiced concern that she has had problems with picc line in past and is concerned about flushes not being sterile.She requested coram test the defective syringes in the event she has to go to the hospital so she can tell them what to treat for.Pharmacy manager, spoke with pt and said we would contact physician to draw blood cultures.Physician office has been contacted.The following information was provided by the initial reporter: pt caregiver called to say that saline was "squirting out the plunger end" when he was trying to flush.They also reported that there were some flushes "still in wrappers" that were empty and others had "dents" in the sides, but were not leaking.The caregiver reported the box is not damaged.Arranged for replacement flushes to be sent and to return all of the flushes in that box and the defective ones so we could inspect them and make a report.Received returned flushes and upon inspection - there were no flushes that were empty in the wrappers, but there were some that were still wrapped and had "dents" in the side of the syringe.A few "used" syringes -also had "dents" in approximately the same spot.No syringes were leaking, even when pressure was applied to the plunger.The caregiver sent back the affected lot # as well as others they had in the house.Called pt caregiver to clarify report of empty syringes in wrappers, and the caregiver said they did throw a few away.Asked about pets in the house, and they do have them but say they do not get into the supplies.Pt voiced concern that she has had problems with picc line in past and is concerned about flushes not being sterile.She requested coram test the defective syringes in the event she has to go to the hospital so she can tell them what to treat for.Pharmacy manager, spoke with pt and said we would contact physician to draw blood cultures.Physician office has been contacted, but we had to leave message with answering service.

Manufacturer Narrative

Investigation: samples received confirmed leakage past stopper.A device history record review was performed for the provided lot number and the review did not reveal any quality issues during the production process that could have contributed to this incident.Leakage past stopper was confirmed however, there were no reports in this lot or other batches produced prior to and subsequent to this batch so a root cause is unassignable in this case.The return samples were inspected and there were no empty packages, therefore the complaint could not be substantiated.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.The samples received as part of this complaint confirms damaged barrels.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.Given the appearance of the damage, it may be consistent with obstruction of the syringe during equipment indexing.The transfer component of the equipment has been inspected and the functions found as normal.The samples received associated with batch 8262617 not confirm damaged barrels.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.The return samples were inspected and there were no damaged barrels.The complaint could not be substantiated.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8551836
• MDR Text Key: 143246495
• Report Number: 9616657-2019-00196
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8232966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention