MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Packaging Problem (3007)

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

Event Date 07/27/2020

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.(b)(4).

Event Description

It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced discolored/stained primary packaging and poor perforation on packaging.Product defects were noted prior to use.The following information was provided by the initial reporter: i wanted to inform you that during a production of a finished product of 096900554v of 8124467 of 4680 pieces, the operators detected brown spots on syringes 76210118 of lot 0118620/518347e.Moreover, the operators have again encountered a problem of seizing on these syringes, the quality agent has made an analysis on the bad parts and has detected that the problem occurs most often on the blister bags with the number 6 imprint: for an order of 4680 pieces : 41 pieces badly degripping on the n°6 imprint.4 pieces badly degripping on impression n°7, 8 pieces badly degripping on impression n°8, 7 pieces badly degripping on impression n°3, 2 pieces with bad release on impression n°1, 2 pieces with bad release on impression n°4.

Event Description

It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced discolored/stained primary packaging and poor perforation on packaging.Product defects were noted prior to use.The following information was provided by the initial reporter: i wanted to inform you that during a production of a finished product of (b)(6) of 8124467 of (b)(4), the operators detected brown spots on syringes (b)(6) of lot 0118620/518347e.Moreover, the operators have again encountered a problem of seizing on these syringes, the quality agent has made an analysis on the bad parts and has detected that the problem occurs most often on the blister bags with the number 6 imprint: for an order of (b)(4): 41 pieces badly degripping on the n°6 imprint.4 pieces badly degripping on impression n°7.8 pieces badly degripping on impression n°8.7 pieces badly degripping on impression n°3.2 pieces with bad release on impression n°1.2 pieces with bad release on impression n°4.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/2/2020.H.6.Investigation: a device history record review was performed for provided lot number 0018620 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 of this issue, both picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, foreign matter was observed on the packaging and poor perforation of the packages was observed.Based on the investigation results, an exact cause for the poor perforation could not be identified as no non-conformances were found for the production of this lot number.This incident will be reviewed with the quality improvement plans for the manufacturing site.The foreign matter on the packaging was identified as markings from the steam sterilization process.The integrity of the product and the sterile barriers have not been affected.These spots appear only on the outside of the packaging and do not permeate in any way onto the product.Furthermore, microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on the packages displaying the brownish stain.The testing confirmed that they do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety of bd posiflush¿ xs 10ml saline flush syringe.H3 other text : see h.10.

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10418054
• MDR Text Key: 204045228
• Report Number: 9616657-2020-00123
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0118620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other