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

Catalog Number 306585

Device Problems Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 07/20/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that foreign growth was found in a culture taken from the bd posiflush¿ saline syringe after the patient developed an infection.The following information was provided by the initial reporter: some patients (around a total of 6 patients) started having infections at the hospital and the staff decided to take culture samples from all of the solutions that are used at the hospital.They also took 1culture sample from our prefilled saline syringes (posiflush sp 10 ml) and proliferation (growth) was observed at the culture sample that was taken.".

Manufacturer Narrative

The following fields were updated due to correction: b.1.Adverse type: adverse event.B.2.Event attributed to: other.B.5.Describe event or problem: it was reported that the patient developed and infection after the bd posiflush¿ saline syringe was used on them.This occurred in 6 patients.H.6.Imdrf annex a grid: a24.

Event Description

It was reported that the patient developed and infection after the bd posiflush¿ saline syringe was used on them.This occurred in (b)(4) patients.The following information was provided by the initial reporter: some patients (around a total of 6 patients) started having infections at the hospital and the staff decided to take culture samples from all of the solutions that are used at the hospital.They also took 1culture sample from our prefilled saline syringes (posiflush sp 10 ml) and proliferation (growth) was observed at the culture sample that was taken.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 15aug2022.H6: investigation summary a device history record review was completed for provided material number 306585 and potential lot numbers 2061328 and 2082968.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, three samples of each potential lot number were returned for evaluation by our quality engineer team.All of the samples were unused; however, one arrived with a torn packaging film and tape.Unfortunately, as the sterility test requires 40 syringes, we were unable to perform the sterility testing on the samples provided by the customer.Forty (40) retained samples from the reported lot numbers were obtained and have been tested for sterility.The test results showed no microbial growth after 14 days.Based on the investigation results, an exact cause related to the manufacturing process could not be determined for this incident.If additional samples are available for this or future incidents, we strongly recommend sending in as many as possible to ensure there is enough to perform any applicable tests.This is a very unusual circumstance.All of the processes which could have affected the sterility of the product were reviewed and no issues were identified.The sterility process was carried out with no issues and the test results of the retained samples show no microbial growth.At this time further action has not been determined necessary.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.

Event Description

It was reported that the patient developed and infection after the bd posiflush¿ saline syringe was used on them.This occurred in 6 patients.The following information was provided by the initial reporter: some patients (around a total of 6 patients) started having infections at the hospital and the staff decided to take culture samples from all of the solutions that are used at the hospital.They also took 1culture sample from our prefilled saline syringes (posiflush sp 10 ml) and proliferation (growth) was observed at the culture sample that was taken.".

• Brand Name: BD POSIFLUSH¿ 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: 15225516
• MDR Text Key: 300447143
• Report Number: 3002682307-2022-00211
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306585
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 10/03/2022
• Supplement Dates FDA Received: 09/15/2022; 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other