MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE; SALINE FLUSH

Catalog Number 306553

Device Problems Device Packaging Compromised (2916); Moisture or Humidity Problem (2986)

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

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Six potential lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 6264805, medical device expiration date: 08/31/2019, device manufacture date: 09/20/2016.Medical device lot #: 7130684, medical device expiration date: 2020, device manufacture date: 05/10/2017.Medical device lot #: 7170621, medical device expiration date: 05/31/2020, device manufacture date: 06/19/2017.Medical device lot #: 7244896, medical device expiration date:08/31/ 2020, device manufacture date: 09/01/2017.Medical device lot #: 7277539, medical device expiration date: 09/30/2020, device manufacture date: 10/04/2017.Medical device lot #: 7319531, medical device expiration date: 10/31/2020, device manufacture date: 11/15/2017.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 the packaging on a 10 ml bd posiflush¿ sf saline syringe was found with a ¿yellow¿ discoloring and looked and felt like it was wet.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation results: a no sample investigation was completed by our quality engineer team.Upon review of the reported information, the discoloration of the syringe packaging was confirmed for all of the provided lot numbers.The stains occur as a result the interaction between the paper and the moist heat sterilization process.Test results have confirmed the stains are cosmetic only in nature and do not permeate through the packaging to the product.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 sf 10ml saline flush syringe.A review of the production history showed no rejected inspections or quality issues for any of the provided lot numbers that could have contributed to this defect.Syringe discoloration, lots 6264805, 7130684, 7170621, 7244896 7277539, & 7319531 no sample received.Dhr 6264805: there were no non-conformances relating to this defect.Dhr 7319531: there were no non-conformances relating to this defect.Dhr 7277539: there were no non-conformances relating to this defect.Dhr 7244896: there were no non-conformances relating to this defect.Dhr 7170621: there were no non-conformances relating to this defect.Dhr 7130684: there were no non-conformances relating to this defect.Risk assessment: in 2017, for this defect type, complaints were reported at an average of 3 per month.Occurrence rate varies between customers, but a total of 26 have been recorded for this specific defect from january to august 2017.Corrective action: required.Capa (b)(4) has been raised following unit level discussions in september 2017.Exceptions: lot numbers manufactured prior to lot 6315951 may have associated staining complaints as a result of sterilizer component issues.This was addressed in capa (b)(4) and the associated corrective action was implemented november 2016.Lot number 6315951 was the first lot number manufactured post corrective action implementation.Lot numbers prior to lot 6315951 may generate customer complaints for staining, these complaints are not within scope of this pic and shall be addressed on an individual basis.A corrective action plan has been implemented to reduce the presence of the brown packaging stains.As no samples were received, bd was unable to confirm the defect of syringe discoloration.

• Brand Name: 10 ML BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7332288
• MDR Text Key: 102326980
• Report Number: 9616657-2018-00008
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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: 306553
• Device Lot Number: SEE SECTION H.10.
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other