MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ STERI-STRIP¿ REINFORCED SKIN CLOSURES; STERI-STRIP SKIN CLOSURES

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pleural Effusion (2010)

Event Date 10/13/1999

Event Type  Injury  

Event Description

The following information was received in a journal article (unilateral pleural effusion complicating central venous catheterisation): a neonatal patient was delivered vaginally at twenty-five weeks gestation and ventilated for three days for surfactant deficient lung disease.After a period of continuous positive airways pressure, the patient was reventilated for apnea secondary to sepsis.The patient was fed parenterally from day to through peripheral veins, and on day three, a 27-gauge silastic catheter was passed into the right atrium through the left saphenous vein.On day ten, acute respiratory distress which failed to respond to increased ventilatory support developed.A chest radiograph documented a large right hydrothorax, with the catheter tip in the right pulmonary vein.Drainage of the hydrothorax and withdrawal of the catheter into the right atrium was accompanied by prompt relief of respiratory distress.A subsequent chest radiograph showed lung clearing, and six days.The catheter was removed without complication.The long saphenous catheter passed via the foramen ovale through the left atrium and into a right pulmonary vein.The development of hydrothorax in this case, the author suggests, is related to increased hydrostatic pressure in a pulmonary vein with resultant shift across the endothelium.There was no evidence of vessel perforation.The resultant pleural transudate led to acute respiratory distress.After removal of pleural fluid and withdrawal of the central venous catheter, there was a rapid and complete recovery.The central venous catheter was secured with 2cm 3m¿ steri-strip¿ reinforced adhesive skin closures (catalog, lot unspecified) crisscrossed under the catheter close to the insertion site.An additional steri-strip overlapped the insertion site.The entire length of catheter was loosely coiled and secured to the skin using 3 cm 3m¿ steri-strip¿ reinforced adhesive skin closures.A 2 × 2 cm gauze sponge (brand unspecified) was placed under the hub.A transparent semipermeable dressing (brand unspecified) was fitted over the insertion site and the entire coiled catheter and the hub.Recommendations made by the author include: "to prevent onward catheter movement, we suggest: (a) four or five overlapping 2 cm steri-strips be applied starting close to the insertion site to secure the catheter to the skin; (b) a square of transparent semipermeable dressing be fitted over the insertion site and steri-strips; (c) the entire length of the catheter is secured to the patient (the catheter is initially loosely coiled and later secured to the skin using narrow strips of transparent semipermeable dressings).".

Manufacturer Narrative

A1, a2, a5-a6: not provided.B3: the date of event was not provided; therefore, entered the date that the article was accepted for publication.D4 & h4: no product lot number was provided and no sample was available.Without a lot number, expiration date and manufacture date could not be determined.H10: a catalog number, lot number and sample were not provided.A medical complaint history review was completed for 3m steri-strip¿ adhesive skin closures and no trend was seen.Complaints will continue to be monitored.The steri-strips were utilized as a securement device and not according to the indications for use noted in the ifu.There fore this event is being reported as a potebtial use error.Per the product ifu: indications for use: steri strip skin closures are indicated for use as a skin closure device in the treatment of lacerations and surgical incisions.To be used by medical professionals.Steri strip skin closures may also be used in conjunction with skin sutures and staples or after their removal for wound support.

• Brand Name: 3M¿ STERI-STRIP¿ REINFORCED SKIN CLOSURES
• Type of Device: STERI-STRIP SKIN CLOSURES
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000
• MDR Report Key: 18584346
• MDR Text Key: 333772102
• Report Number: 2110898-2024-00007
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DRESSING (BRAND NAME UNKNOWN); SPONGE GAUZE
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male
• Patient Weight: 1 KG