MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number 306547

Device Problem Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that while using a 10 ml bd posiflush¿ normal saline syringe, the pump used was ¿set off¿.There was no report of injury or medical intervention.

Manufacturer Narrative

Correction: original mdr was listed as a death.This information is incorrect, there was no patient death reported with this complaint.The correct type of reportable event is a malfunction.

Manufacturer Narrative

Investigation results: update feb09, 2018.The sample received has a barrel label with lot#726888; this complaint was filed against lot#7108920.A sample was received in the columbus plant for evaluation.It came in a (b)(6) plastic bag.The barrel label has the lot#7268688.It has the plunger rod-stopper all the way down.It has no tip cap and saline solution.The plunger rod-stopper was pulled up to the 10ml mark then the break out force was measured giving 10.80 n.The spec is <20n; therefore it is within spec.And failure mode is not verified.There was no documentation of issues for the complaint of batch 7208920 during this production run.All our inspections performed while manufacturing this batch were accepted; no rejections were documented.There were no quality notifications issued during the production of this batch listed in the complaint.Root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There were no issues documented about plunger movement difficult.

Manufacturer Narrative

Result: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was unable to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7059802
• MDR Text Key: 93726362
• Report Number: 1911916-2017-00317
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2018

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 Expiration Date: 07/31/2020
• Device Catalogue Number: 306547
• Device Lot Number: 7208920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 11/01/2017; 11/01/2017; 11/01/2017
• Supplement Dates FDA Received: 11/27/2017; 01/11/2018; 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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